Gehaltsübersicht für Pharmacovigilance in Schweiz

 After the process rolls out, the single Business Process Leaders ensure implementation feedback is collected and escalate needs for changes to the global process. The team establishes with the affiliates and all its stakeholders quality and compliance with PV policies and processes and is driving process-level inspection readiness as the norm. Tasks & Responsibilities:Lead the affiliate working group involved for consultation on the processesIPV Business Process Management (IPV BPM) is the contact and collaboration point for the contractorIPV Business Process Management and EU Country Cluster Leads create an Affiliate Safety working group and the contractor would be coordinating this group representing IPV BPMWork closely with the affiliate working group member being part of the community of practice (CoP) for Clinical TrialsThe person should ideally have EU clinical trial and PV experience. They will be a part of relevant workstreams (ICSR process, ICSR systems, Reference Safety Information, Process) and lead the affiliate working group involved for consultation on the processesMust haves:Bachelor’s or Master’s degree in pharmacy or a science related field Minimum 7 to 10 years of experience within pharmacovigilance in industry with experience on the following: Headquarter Pharmacovigilance support to Investigational Clinical trials ; Headquarter Pharmacovigilance interactions with Local Safety Units ; Set-up of Global Clinical Trials in various geographies in the EEA; Knowledgeable of UK Exit situation for Pharmacovigilance and MHRA expectationsExperience working with safety in a clinical trial environment: ICSR reporting within the EEA Experience interacting from headquarter to local/affiliates Competencies /soft skills of the candidate:Ownership and accountabilityDecision makingStrong communication, influencing and negotiation skills.Strong interpersonal skills and partnering skills. Able to work efficiently and effectively in cross functional and matrix teams

Risk Management Expert (Pharma) About Us Consultys Group is a 100% specialist LifeScience consulting firm. With more than 550 experts working in France, Belgium, Germany and Switzerland on major engineering, R&D and compliance projects for the world’s leading pharmaceutical, medical device and biotech companies. Consultys links operational compliance, quality, processes, R&D, regulatory, own solutions and technology in ways that master complex business challenges to help its LifeScience clients exploit their existing strengths and develop new capabilities by combining its experience and innovative thinking across in the regulated environment. Role & Responsibilities Execute and support all local pharmacovigilance and Risk Management (RM) related activities Communicate efficiently and effectively with Local Service Providers to support timely processing of orders and ensure compliance to RMPs Collaborate with supply chain and customer care to perform reconciliation of Prescription Authorization Forms (PAFs) submission against supply Contribute to the development, update and maintenance of SOPs/WPs and associated documents Complete adverse event reconciliations for vendors involved in, but not limited to, patient support programs, medical information and investigator-initiated trials on a frequency determined by the agreement Review and input into safety sections of abbreviated prescribing information for newly authorized medicines and for updated Summary of Product Characteristics (SmPCs) Requirements University Degree in Sciences, Engineering or another relevant disciplines 3 years of experience in the production of active ingredients and in the GMP environment (experience in biotechnological production is an advantage) At least 2 years of experience in the application of quality risk management methods Analytical and structured working style; strong attention to detail Ability to effectively work as part of a multidisciplinary, international team Fluency in English is required, German, French or Italian would be a plus

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Senior Scientific Advisor (sSA) is responsible to actively engage with Thought Leaders (TL), Health Care Professionals (HCPs) to serve as the Therapeutic Area (TA) reference point within their geographic scope. The sSA is responsible to design and deliver a medical plan, consistent with global medial strategic imperatives and in collaboration with local Representatives (Partners). sSA provides medical support to internal matrix Local Representatives (Partners) as well as fosters effective and open relationships with them. sSA supports Brand Strategies development in collaboration with BMS Marketing by communicating medical insights and drug or disease area knowledge with reference to patients’ needs and treatment trends. Key Responsibilities External Environment and Customer Focus Profile the medical landscape in the focused countries within the Disease Area and continuously update this knowledge, including knowledge and expertise in products, patient treatment trends, unmet medical needs, clinical trials and scientific activities, Role model in developing and maintaining peer-to-peer relationships and close contacts with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer unsolicited product and HEOR related questions, Master proficiency in available scientific resources and presentations and effectively present information to HCPs, as appropriate, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives, Actively profile the medical and competitive landscape to effectively evolve planning at the market level within the medical team and matrix leadership teams, as appropriate. Collect, analyze and present meaningful medical insights back to the medical and commercial organizations at brand team meetings to be actioned in support of the strategy development, Identify the need for and execute local Advisory Boards, Propose scientifically meaningful medical programs such as Continuous Medical Educational (CME) programs and Symposia and ensure flawless execution of such activities, Provide scientific information to and collaborate with Local Representatives-Partners (LR-P) relevant functions. Support Clinical Trial Activities Contribute to the “early prioritization” of development programs of Local Representatives countries by collating and integrating data on disease incidence/prevalence, treatment patterns, unmet medical needs and interest from the scientific community, as appropriate. Serve as point of reference for compounds in early development Actively track study performance and contribute with insights and solutions Ensure that BMS Pharmacovigilance procedural documents are understood and applied by Investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Medical Planning/Execution Deliver scientifically meaningful medical programs and ensure flawless execution of medical activities to support overarching medical plan execution (e.g. Advisory Boards, Expert Exchange Meeting, Satellite Symposia, etc.), Contribute to the development of Brand Plans and Brand Strategies by communicating medical insight and product or disease area knowledge with reference to patients needs and treatment trends, Participates in the development of the Local Medical Plan, work with local representatives (partners) to deliver Local Medical Plan, contribute to the overall Marketing Plan by leveraging medical insight and product or disease area knowledge of recent scientific publications, Discuss and deliver Health Economics and Outcomes Research (HEOR) evidence-based information reactively (ie, to government agencies, healthcare organizations, and payers), as appropriate, Work with the PV responsible to help ensure that all the information regarding AEs in the field is collected, to facilitate the correct and transparent communication of AEs internally and to the competent Health Authorities externally. Medical support for internal stakeholders Contribute to the initial and ongoing medical/scientific disease area and product-specific training of internal BMS stakeholders (specifically to Commercial, Regulatory, Pharmacovigilance, Legal Counsel and Market Access), Investigational Site staff, Site Managers and Monitors in BMS products, Contribute to, supervise and coordinate the development of the medical / scientific sections of pricing and reimbursement files, Contribute to the development and review of non- promotional material (consistent with the Non-Promotional Review SOP) and participates in the review process of Risk Minimization Materials/ARMA materials. Compliance Endorse and implement a culture of compliance, Adhere to all internal and external rules and regulations, Alert management or the Compliance Department to any possible compliance issues, Act as a role model who demonstrates consistent ethical and professional behavior. Qualifications & Experience Advanced scientific or medical degree (PharmD, PhD, MD), Experience Requirements Relevant industry experience in Medical Affairs/Clinical Development. Experience in a customer-facing role with thought leaders and key customers preferred, Ability to work effectively with cross functional teams including clinical, commercial, regulatory, pharmacovigilance and health outcomes as well as and market-based medical colleagues, Ability to communicate scientific or clinical data in an understandable and valuable manner to help HCPs best serve their patients, Broad experience in Immune/Inflammatory disease area with specific expertise in clinical development is preferred, Experience with investigator sponsored research, non-registrational studies, and early patient access programs preferred, Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills. Key Competency Requirements Expert knowledge in Immunology & Inflammatory disease area, ideally Psoriasis, scientific or clinical area, Experience in the EMEA (LR-EU) region health care environment & knowledge of local regulations, Developing field medical plans aligned with medical and overall disease & product objectives, Strong communication and presentation skills, Fluent in English, Compliance & Integrity. Travel Requirement Extensive travel (30% time). If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:0126 Bristol-Myers Squibb Kft

Ihr Einsatz für Sicherheit und Freiheit An einem abwechslungsreichen und vielseitigen Arbeitsplatz mit attraktiven Anstellungsbedingungen führen Sie als Leiter/in Regulatory Affairs den Bereich Zulassungen, tragen die Verantwortung im Bereich Pharmacovigilance und leisten somit einen wichtigen Beitrag zur Auftragserfüllung der Schweizer Armee. Wir bieten Ihnen eine verantwortungsvolle und vielfältige Funktion mit sinnstiftenden Aufgaben und interessanten Herausforderungen in der Armeeapotheke. In einem dynamischen Umfeld gestalten Sie die zukünftige Ausrichtung und Leistungserbringung mit. Werden Sie Teil unseres Teams.Ihre AufgabenDen Bereich "Regulatory Affairs" der Armeeapotheke leiten und als Hauptkontaktperson für die Zulassungs-Aktivitäten der Arzneimittel sowie anderer Produkttypen wie Chemikalien und Bioziden gegenüber den Zulassungsbehörden die Verantwortung tragen Die bestehenden Zulassungen über den ganzen Life-Cycle der Produkte pflegen und betreuen Die Bereiche Entwicklung und Qualitätssicherung in Bezug auf regulatorische Aspekte und Bestimmungen fachlich unterstützen Sich mit juristischen Fragestellungen im Bereich "Drug Regulatory Affairs" sowie anderer Produkttypen auseinandersetzen Als verantwortliche Person Pharmacovigilance u.a. regelmässige Reportings mit Berichten zu Anwendungsbeobachtungen in deutscher Sprache zu Handen der Zulassungsbehörde verfassen Ihr ProfilHochschulabschluss (Master) in Pharmazie, Chemie oder Biologie mit 4-7 Jahren funktionsrelevanter Erfahrung Berufserfahrung im Bereich Pharmacovigilance eines Pharma-Betriebs Sehr gute Kenntnisse der GMP-Methodik, gute MS-Office-Kenntnisse Belastbare, kommunikative und authentische Persönlichkeit mit hoher Sozialkompetenz und kooperativem Führungsstil; Führungs- und Teamfähigkeit, Durchsetzungsvermögen sowie strategisches Denken und Handeln werden vorausgesetzt Gute aktive Kenntnisse mindestens einer zweiten Amtssprache und passive Kenntnisse einer dritten Amtssprachen Zusätzliche InformationenFür weitere Auskünfte wenden Sie sich bitte an: Nicole Balsiger, Chefin Pharmaprodukte und -Technik 058 489 14 61,[ [email protected] ](mailto: [email protected] ?subject=)Eine Anstellung bei der Schweizer Armee macht Sinn und bringt viele Vorteile mit sich. Überzeugen Sie sich auf armee.ch/vorteile. Über unsDie Logistikbasis der Schweizer Armee (LBA) ist für die Truppe da. Sie erbringt sämtliche logistische Leistungen für die Schweizer Armee und bewirtschaftet mit ihren rund 3'500 Mitarbeitenden und den 12'000 Milizangehörigen das Material, die Systeme und die Infrastrukturen der Schweizer Armee. Ob Automobil-Mechatroniker/in, Spezialist/in Alarmzentrale oder Projektleiter/in Interaktive Medien: Die LBA bietet schweizweit ein breites Spektrum an Arbeitsplätzen.Die Schweizer Armee beschäftigt über 9'000 Mitarbeitende in vier militärischen und rund 200 zivilen Berufen -- und dies an 140 Standorten schweizweit. Auch für den Nachwuchs ist gesorgt: Die Schweizer Armee bildet in über 30 Berufen Lernende aus.Worblentalstrasse 36, 3063 IttigenDie Bundesverwaltung achtet die unterschiedlichen Bedürfnisse und Lebenserfahrungen ihrer Mitarbeitenden und fördert deren Vielfalt. Gleichbehandlung geniesst höchste Priorität.Mitarbeitende aus der französischen und der italienischen Sprachengemeinschaft sind in unserer Verwaltungseinheit untervertreten. Bewerbungen von Personen dieser Sprachgemeinschaften sind deshalb besonders willkommen.Schweizer Armee - Logistikbasis der Armee LBA Vakant seit : 10.01.2024 Anzahl Stellenangebote : 1 3063 Ittigen (BE) 80% - 100% Ab Sofort Unbefristet Die Schweizer Armee - Logistikbasis der Armee LBA sucht:Leiter/in Regulatory Affairs80%-80% / Ittigen

An einem abwechslungsreichen und vielseitigen Arbeitsplatz mit attraktiven Anstellungsbedingungen führen Sie als Leiter/in Regulatory Affairs den Bereich Zulassungen, tragen die Verantwortung im Bereich Pharmacovigilance und leisten somit einen wichtigen Beitrag zur Auftragserfüllung der Schweizer Armee. Wir bieten Ihnen eine verantwortungsvolle und vielfältige Funktion mit sinnstiftenden Aufgaben und interessanten Herausforderungen in der Armeeapotheke. In einem dynamischen Umfeld gestalten Sie die zukünftige Ausrichtung und Leistungserbringung mit. Werden Sie Teil unseres Teams.Ihre AufgabenDen Bereich "Regulatory Affairs" der Armeeapotheke leiten und als Hauptkontaktperson für die Zulassungs-Aktivitäten der Arzneimittel sowie anderer Produkttypen wie Chemikalien und Bioziden gegenüber den Zulassungsbehörden die Verantwortung tragenDie bestehenden Zulassungen über den ganzen Life-Cycle der Produkte pflegen und betreuenDie Bereiche Entwicklung und Qualitätssicherung in Bezug auf regulatorische Aspekte und Bestimmungen fachlich unterstützenSich mit juristischen Fragestellungen im Bereich "Drug Regulatory Affairs" sowie anderer Produkttypen auseinandersetzenAls verantwortliche Person Pharmacovigilance u.a. regelmässige Reportings mit Berichten zu Anwendungsbeobachtungen in deutscher Sprache zu Handen der Zulassungsbehörde verfassenIhr ProfilHochschulabschluss (Master) in Pharmazie, Chemie oder Biologie mit 4-7 Jahren funktionsrelevanter ErfahrungBerufserfahrung im Bereich Pharmacovigilance eines Pharma-BetriebsSehr gute Kenntnisse der GMP-Methodik, gute MS-Office-KenntnisseBelastbare, kommunikative und authentische Persönlichkeit mit hoher Sozialkompetenz und kooperativem Führungsstil; Führungs- und Teamfähigkeit, Durchsetzungsvermögen sowie strategisches Denken und Handeln werden vorausgesetztGute aktive Kenntnisse mindestens einer zweiten Amtssprache und passive Kenntnisse einer dritten AmtssprachenZusätzliche InformationenFür weitere Auskünfte wenden Sie sich bitte an:Nicole Balsiger, Chefin Pharmaprodukte und -Technik058 489 14 61, [email protected] Eine Anstellung bei der Schweizer Armee macht Sinn und bringt viele Vorteile mit sich. Überzeugen Sie sich auf armee.ch/vorteile. Referenznummer: JRQ$540-9083 Über unsDie Logistikbasis der Schweizer Armee (LBA) ist für die Truppe da. Sie erbringt sämtliche logistische Leistungen für die Schweizer Armee und bewirtschaftet mit ihren rund 3'500 Mitarbeitenden und den 12'000 Milizangehörigen das Material, die Systeme und die Infrastrukturen der Schweizer Armee. Ob Automobil-Mechatroniker/in, Spezialist/in Alarmzentrale oder Projektleiter/in Interaktive Medien: Die LBA bietet schweizweit ein breites Spektrum an Arbeitsplätzen.Die Schweizer Armee beschäftigt über 9'000 Mitarbeitende in vier militärischen und rund 200 zivilen Berufen – und dies an 140 Standorten schweizweit. Auch für den Nachwuchs ist gesorgt: Die Schweizer Armee bildet in über 30 Berufen Lernende aus.Die Schweizer Armee - Logistikbasis der Armee LBA sucht:Leiter/in Regulatory Affairs80%-80% / IttigenIhr Einsatz für Sicherheit und Freiheit

Job Description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. In this position you are working for a leading biopharmaceutical company with a diversified portfolio of prescription medicines and vaccines. The company has longstanding commitment to prevent and treat diseases and invests significantly in research and development to address unmet public health needs with innovative treatment options. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an addition to our Global Clinical Trial Operations Team and based in Lucerne, we are looking for a Clinical Trial Coordinator (CTC) (permanent full-time contract). As a Clinical Trial Coordinator you are responsible for comprehensive trial and site administration in Switzerland and in Austria. The person prepares, collates, distributes and archives clinical documents and ensures timely maintenance of tracking and reporting tools. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to ethics committees (ECs) and health authorities. The CTC is collaborating at local level closely with the country operations manager (COM), the project manager (CRM) and the clinical research associate (CRA). Furthermore, the CTC is managing payments according to contracts with clinical trial sites. The primary activities include but are not limited to: Trial and site administration: Track (e.g. essential documents) and report (e.g. Safety Reports) Ensure collation and distribution of study documents Update databases and trackers Document management: Prepare documents and correspondence Collate, distribute/ship, and archive clinical documents, e.g. eTMF Prepare Investigator trial file binders Regulatory & Site Start-Up responsibilities, collaborate with other country roles to: Provide to and collect from investigators forms/lists for site start-up and submissions Obtain, track and update study insurance certificates Support preparation of submission package for ECs and support health authority submissions. Budgeting, Agreement and Payments, collaborate with finance/budgeting representatives for: Calculate and execute payments to investigators Control trial site payments against budget, track payments from site set-up until close-out Ensure adherence to financial and compliance procedures Maintain tracking tools Qualifications: Bachelor’s or Master’s Degree in Life Science, Biology or equivalent or completed job training in office management/administration/finance Previous experience in clinical research or relevant healthcare experience Good understanding of clinical research guidelines and the local regulatory environment Fluent in German and English (verbal and written), Italian and/or French would be an asset Strong coordination, organizational, and time management skills High sense of accountability and urgency in order to properly prioritize and handle multiple tasks simultaneously in a changing environment Ability to work effectively in office but also remote/virtual environment with a wide range of people Positive mindset, growth mindset, work independently with assigned tasks Proactive attitude to solving problems/proposing solutions Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Interested in becoming part of a dynamic, developing team and contributing your know-how to an innovative environment that allows you to show initiative and that offers long-term perspectives? Please apply using the link to our career site! We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. THE COMPANY We are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. Our Company has had a presence in Switzerland since 1963 and employs around 1000 people at five sites in the cantons of Lucerne and Zurich. We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” since 2012 showing the company’s commitment to our employees and the community around us. The Switzerland Head Office is based in Lucerne's city center. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: On-Site Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Über das Unternehmen:1204 MSD Merck Sharp&Dohme AG

Tillotts is looking for a dynamic and motivated IT Application Manager at its headquarters in Rheinfelden, Switzerland.Manager QA / EU QP Deputy | Tillotts GlobalPrivacy notice:All the information and personal data you will hereby share with Tillotts Pharma will be protected and kept confidential in line with internal procedures and local regulations. Your information and personal data will be used for the purpose of drug safety surveillance and to enable us to deal with your enquiry appropriately and it may be shared with such other parties with whom Tillotts Pharma shares responsibility for pharmacovigilance (study of drug-related safety information) for Tillotts Pharma’s products in your country of residence, and/or with health authorities. In this context, your personal data may be transferred within your country of residence, the European Economic Area, and/or a country that the European Commission has decided provides adequate protection for personal data. For more information about how we collect and use your personal data, and your rights with respect to your personal data, please see our privacy notice which is available on our website at Ochrana osobních údaj?:Veškeré informace a osobní údaje, které budete tímto sdílet se spole?ností Tillotts Pharma, budou chrán?ny a bude s nimi zacházeno jako s d?v?rnými v souladu s vnit?ními postupy a místními p?edpisy. Vaše informace a osobní údaje budou používány pro ú?ely sledování bezpe?nosti léku a k tomu, abychom mohli ?ádn? odpovídat na vaše dotazy. Tyto informace a osobní údaje mohou být sdíleny se t?etími stranami, se kterými spole?nost Tillotts Pharma sdílí zodpov?dnost za sledování bezpe?nosti farmaceutických p?ípravk? (klinické hodnocení bezpe?nostních informací spojených s léky) u produkt? spole?nosti Tillotts Pharma ve vaší zemi trvalého pobytu a/nebo se zdravotními orgány. V tomto kontextu mohou být vaše osobní údaje p?evád?ny v rámci zem? vašeho trvalého pobytu, Evropského hospodá?ského prostoru a/nebo zem?, o které Evropská komise rozhodla, že má dostate?nou ochranu osobních údaj?. Další informace o tom, jak shromaž?ujeme a používáme vaše osobní údaje a o vašich právech týkajících se vašich osobních údaj? naleznete v našem prohlášení o ochran? osobních údaj?, které je k dispozici na našich webových stránkách na Meddelelse om beskyttelse af personlige oplysninger:Alle de oplysninger og personoplysninger, du hermed deler med Tillotts Pharma, bliver beskyttet og opbevaret fortroligt i overensstemmelse med interne procedurer og lokale bestemmelser. Dine oplysninger og personoplysninger vil blive brugt med henblik på overvågning af lægemiddelsikkerheden og gør det muligt for os at behandle din forespørgsel på passende vis, og kan blive delt med sådanne andre parter, med hvem Tillotts Pharma deler ansvaret for overvågning af lægemiddelrelaterede sikkerhedsoplysninger for Tillotts Pharmas produkter i dit bopælsland, og/eller med sundhedsmyndighederne. I den forbindelse kan dine personoplysninger blive overført inden for dit bopælsland, Det Europæiske Økonomiske Samarbejdsområde og/eller et land, som Europa-Kommissionen har besluttet yder tilstrækkelig beskyttelse af personoplysninger. For yderligere oplysninger om, hvordan vi indsamler og bruger dine personoplysninger, og dine rettigheder med hensyn til dine personoplysninger, kan du se vores meddelelse om beskyttelse af personlige oplysninger, som er tilgængelig på vores hjemmeside på Déclaration de confidentialité:Toutes les informations et données personnelles que vous communiquez à Tillotts Pharma seront protégées et tenues confidentielles conformément aux procédures internes et aux réglementations locales. Vos informations et données personnelles seront utilisées à des fins de pharmacovigilance et pour nous permettre de traiter votre demande de manière appropriée. Elles pourront être communiquées aux autres parties avec lesquelles Tillotts Pharma partage la responsabilité de la pharmacovigilance (étude des informations de sécurité relatives aux médicaments) pour les produits de Tillotts Pharma dans votre pays de résidence ou auprès des autorités sanitaires. Dans ce contexte, vos données personnelles peuvent être transférées dans votre pays de résidence, dans l’Espace économique européen ou dans un pays où la Commission européenne a décidé d’assurer une protection adéquate des données personnelles. Pour plus d’informations sur la façon dont nous collectons et utilisons vos données personnelles et vos droits en ce qui les concerne, veuillez consulter notre déclaration de confidentialité disponible sur notre site Web à l’adresse Tietosuojailmoitus:Kaikkia Tillotts Pharmalle luovuttamiasi tietoja ja henkilötietoja suojataan ja pidetään luottamuksellisina sisäisten menettelytapojen ja paikallisten määräysten mukaisesti. Tietojasi ja henkilötietojasi käytetään lääketurvallisuuden valvonnan tarkoituksessa, jotta voimme käsitellä ilmoituksesi asianmukaisesti.Niitä voidaan luovuttaa muille sellaisille osapuolille, joiden kanssa Tillotts Pharma on yhdessä vastuussa Tillotts Pharman tuotteiden lääketurvallisuuden valvonnasta (lääkkeisiin liittyvien turvallisuustietojen tutkimus) asuinmaassasi, ja/tai terveysviranomaisille. Tässä yhteydessä henkilötietojasi voidaan siirtää asuinmaasi, Euroopan talousalueen ja/tai sellaisen maan sisällä, joka Euroopan neuvoston päätöksen mukaan tarjoaa riittävän henkilötietojen suojauksen. Lisätietoja siitä, miten keräämme ja käytämme henkilötietojasi, sekä henkilötietojasi koskevat oikeutesi on esitetty tietosuojailmoituksessamme, joka on luettavissa verkkosivullamme Datenschutz:Alle Informationen und personenbezogenen Daten, die Sie hiermit mit Tillotts Pharma teilen, werden in Übereinstimmung mit unseren internen Verfahren und den lokalen Vorschriften geschützt und geheim gehalten. Ihre Informationen und personenbezogenen Daten werden zum Zweck der Überwachung der Arzneimittelsicherheit verwendet und um uns in die Lage zu versetzen, Ihre Anfragen angemessen zu bearbeiten. Ihre Informationen werden gegebenenfalls mit den Gesundheitsbehörden und/oder anderen Parteien geteilt, mit denen gemeinsam Tillotts Pharma die Verantwortung für die Pharmakovigilanz (Studien zur Arzneimittelsicherheit) von Tillotts Pharmaprodukten in Ihrem Aufenthaltsland trägt. In diesem Kontext werden Ihre personenbezogenen Daten gegebenenfalls innerhalb Ihres Aufenthaltslandes, des Europäischen Wirtschaftsraums und/oder innerhalb eines Landes, das nach Entscheidung der EU-Kommission einen ausreichenden Schutz Ihrer personenbezogenen Daten gewährleistet, übermittelt. Für weitergehende Informationen darüber, wie wir Ihre personenbezogenen Daten sammeln und verwenden und bezüglich Ihrer Rechte an Ihren personenbezogenen Daten, sehen Sie sich bitte unseren Datenschutzhinweis an, der auf unserer Webseite vorliegt unter Datenschutz Tilkynning um persónuvernd:Allar upplýsingar og persónuleg gögn sem þú deilir með Tillotts Pharma verða varin og geymd í trúnaði í samræmi við verklagsreglur og gildandi lög. Upplýsingar þínar og persónuleg gögn verða notuð til eftirlits með öryggi við notkun lyfja og til að gera okkur kleift að bregðast rétt við erindi þínu. Einnig gæti þeim verið deilt með aðilum sem bera ásamt Tillotts Pharma ábyrgð á lyfjagát (eftirlit með öryggi við notkun lyfja) fyrir vörur frá Tillotts Pharma í því landi þar sem þú átt heima og/eða með heilbrigðisyfirvöldum. Í því tilfelli gætu persónuleg gögn þín verið send til annarra aðila innan heimalands þíns, Evrópska efnahagssvæðisins og/eða annars lands sem Framkvæmdastjórn Evrópusambandsins hefur ákveðið að veiti fullnægjandi vernd fyrir persónuleg gögn. Frekari upplýsingar um hvernig við söfnum persónulegum gögnum og notum þau og um réttindi þín hvað varðar persónuleg gögn þín er að finna í tilkynningu okkar um persónuvernd á vefsíðu okkar: PersonvernerklæringAll informasjon og personopplysninger du hermed deler med Tillotts Pharma blir beskyttet og behandlet fortrolig i samsvar med interne prosedyrer og lokale forskrifter. Din informasjon og dine personopplysninger vil bli brukt for overvåking av legemiddelsikkerhet og for å sette oss i stand til å håndtere din forespørsel riktig, og de kan deles med andre som Tillotts Pharma deler ansvar med for farmakovigilans (legemiddelrelatert sikkerhetsinformasjon) for Tillotts Pharmas produkter i det landet der du bor og/eller helsemyndigheter. I denne sammenhengen kan dine personopplysninger overføres innenfor det landet du bor i, Det europeiske økonomiske samarbeidsområdet og/eller et land som EU-kommisjonen har besluttet, gir tilstrekkelig beskyttelse av personopplysninger. For mer informasjon om hvordan vi samler inn og bruker dine personopplysninger, og dine rettigheter når det gjelder dine personopplysninger, vennligst se vår personvernerklæring på vårt nettsted: Aviso de privacidad:Toda la información y datos personales que usted comparta aquí con Tillotts Pharma estarán protegidos y se mantendrán como confidenciales de acuerdo con los procedimientos internos y las normativas locales. Sus datos personales y su información se utilizarán para controlar la seguridad del fármaco y para que podamos ocuparnos debidamente de su consulta; por lo tanto es posible que se compartan con cualesquiera socios que tengan responsabilidad conjunta con Tillotts Pharma por la farmacovigilancia (el estudio de la información de seguridad relativa al fármaco) de los productos de Tillotts Pharma en su país de residencia, así como con las autoridades sanitarias. En este contexto, sus datos personales pueden ser transferidos dentro de su propio país de residencia, dent23.01.2024 100% Festanstellung

The medical information manager will be handing complex Medical information inquiries in second line. The main tasks include but are not limited to the following task areas:Ensuring appropriate, quality and timely responses to requests for medical information in EMEA for therapeutic areas of responsibilityInternally or in collaboration with Medical Communications and Global Medical Teams, developing and ensuring communication of timely, accurate responses to unique and escalated inquiresCollaborating with the Medical Information Operations Lead to monitor the KPIs and define continuous education strategy. Support contracting and compliant delivery of vendor services, including call center setup and implementation, ongoing training and reporting.Supporting novel channels for dissemination of medical information and new digital technologies and systems in accordance with digital strategyManaging medical information providersDeveloping and implementing medical information support materials in coordination with Global Medical Teams and Medical Communications, as well as Local Medical Information teams, where appropriate materials (e.g. Standard Response Letters, Frequently Asked Questions)Ensuring reporting of potential adverse events and product quality complains to appropriate teamsIn order to be considered for the role, the selected candidate must have:Master Degree in a life sciences discipline5 years work experience in a medical/scientific field in the industry, 2 years of experience within medical affairs, clinical research or PV/safety roles (e.g. Medical Information, Medical Communications, Pharmacovigilance/Safety)Understanding of the structure and cross-functional collaboration of different functions in a pharma company (e.g. medical affairs, PV, medical communication, drug safety, Quality Assurance, Regulatory Affairs, etc.)Experience managing vendors and complex projects is requiredGood knowledge of medical information best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelinesWorking with Salesforce, Veeva Vault and typical research data basesStrong communication skills in English, and another European language e.g. Italian, French or Spanish, is an advantage

Regulatory Affairs Manager (f/m/d) The Global Regulatory Affairs department of the B. Braun Avitum division has an opportunity for a Regulatory Affairs Managerlocated at our site in Sempach, Switzerland. In our plant in Sempach, we develop and produce a broad range of products for cleaning and disinfecting instruments, biocidal products for hand and surface disinfection as well as medicinal products for use on skin and in wounds. Diversity is a part of B. Braun Avitum AG. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.We are looking for a passionate and talented individual who will act as an entrepreneur of the global infection preventionportfolio. Find out more about our Sempach site. and why it is worth working for B. Braun. Tasks & Responsibilities Worldwide marketing authorisation and regulatory support for biocides and cosmetics Creation of regulatorydocumentation (R4BP, PIF) for acquiring and maintaining registrations Handle variations to the dossier in accordance with the Change Control process Prepare responses to requests by the Competent Authorities during the evaluation process, and timely handle deficiency letters within a specific timeframe Create and maintain a full up-to-date database and archiving system for tracking the local Regulatory dossiers in the region Effective communication and cross-functional interaction with all involved departments, both on a Regional and Global levels (Regulatory Affairs, Quality Assurance, Quality Control, Production area, Medical Affairs, Marketing) Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/Medical Affairs Build collaborative relationships with decision-makers and opinion leaders to understand current issues and recognize future trends in the market Professional skills University education in the natural sciences (pharmacy, chemistry, biology) Further training in the area of regulatory affairs (EU, CH, USA, Asia) would be an advantage Experience in the registration of biocides and cosmetics Very good written and spoken English and German skills (any additional skills are beneficial) Personal skills Analytical and structured way of thinking and working High organizational and communication skills Good teamwork and interpersonal skills What we offer Our promise is Sharing Expertise. The B. Braun company began with a passion for positive change. To this day, we attract people who express progressive ideas and implement them together with trust, transparency and appreciation. Because all follow the same vision: At B. Braun, we protect and improve the health of people worldwide.

CMC Regulatory Affairs Manager – PharmaLocationWestschweizContract typepermanent jobYour tasks:You will be responsible for leading the post-market activities of drug products development and maintenance of registration files, developing & leading the regulatory strategies within your territory, including maintenance of API DMFResponsible for preparing & reviewing regulatory submissions (CMC, module 3 especially), maintaining registration files & DMF drug products (FDA), NDA, MRP, DCP submissions, SwissMedic complianceYou will be the main point of contact for pharmacovigilance activities, maintaining policies & regulatory intelligence.Provide regulatory strategies for projects as RA representativeYour profile:MSc or PhD degree in Pharmacy, Biotechnology, Biology, Microbiology, Chemistry or related mattersMin of 4+ years' experience with proven track record in a GMP production site as CMC Regulatory Affairs Specialist / Manager (RA CMC) within the pharmaceutical sphere & / or for a biotech or CRO (required)At your ease with CTA, INDs, IMPs writing & reports. Experience with parenteral drug: an assetStrong knowledge of Regulatory Affairs with Clinical Drug Development standardsExcellent experience in handling regulatory obstacles, you are a problem solver with ability to deal with a fast-paced environmentAutonomous, curious & deeply passionate about the life sciences sphere, you have an entrepreneurial spirit and breath innovationFluent in English. French would be an asset