Gehaltsübersicht für Pharmacovigilance in Schweiz
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Gehaltsübersicht für Pharmacovigilance in Schweiz
2 930 ₣ Durchschnittliches Monatsgehalt
Durchschnittliches Gehaltsniveau in den letzten 12 Monaten: "Pharmacovigilance in Schweiz"
Das Balkendiagramm zeigt die Änderung des Gehaltsniveaus in der Pharmacovigilance Branche in Schweiz
Verteilung des Stellenangebots "Pharmacovigilance" in Schweiz
Wie die Grafik zeigt, in Schweiz gilt Basel-Stadt als die Region mit der größten Zahl der offenen Stellen in und an zweiter Stelle folgt Kanton Luzern. Den dritten Platz nimmt Freiburg ein.
Ranking der ähnlichen Stellenangebote gemäß dem Gehaltsniveau in Schweiz
Wie die Grafik zeigt, in Schweiz gilt Basel-Stadt als die Region mit der größten Zahl der offenen Stellen in und an zweiter Stelle folgt Kanton Luzern. Den dritten Platz nimmt Freiburg ein.
Associated Business Process Leader, ICSR Process
Coopers Group AG, Basel-Stadt
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
Associate Director, Signal Management
Randstad (Schweiz) AG, Basel
Randstad Professionals is looking for an Associate Director, Signal Management for a major client. This position will be based in Basel .Startdate: ASAP (up to 3 month notice period possible)Contract: 12 monthsThis position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities:Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: Lead all signal management activities for assigned product(s) Support implantation of signal detection strategy approved by VP of Pharmacovigilance Review adverse event data, literature and other safety-related data for the purpose of signal detection Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans Partner with the Director, Pharmacovigilance – Signal Management to oversee digital signal detection and management tool. Serve as an administrator of the tool Propose and implement signal detection methods in the tool Train, mentor and assist CSRM staff in using the tool. Oversee signal tracking and signal notifications to external stakeholders Generate periodic signal management compliance metrics Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management. Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues Draft regulatory response documents such as PRAC assessment reports Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance Excellent written and verbal communication skills with the ability to interpret and present safety data Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process Knowledge of drug safety/pharmacovigilance practices and tools Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision Background in vaccines is a plus Demonstrated ability to develop, execute and follow-through complex projects to completion Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view Independently motivated, detail oriented and strong problem-solving ability Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position.
Head of Pharmacovigilance (m/f/d)
Viatris, Zug, CH
7087 Mylan Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of geography or circumstance; Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and Partnership - Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how the Head of Pharmacovigilance role will make an
Clinical and Pharmacovigilance Quality Assurance Senior Manager
jobup.ch, Geneve, Switzerland
ompharma.com Clinical and Pharmacovigilance Quality Assurance Senior Manager In view of our continued global growth, we are looking for further support and recruiting a Clinical and Pharmacovigilance Quality Assurance Senior Manager at our biotech production site in Geneva. Your specific mission is to Ensure that our Clinical and Pharmacovigilance Quality Assurance team and system meets standards expected by health authorities and global regulatory authorities. Reporting to the Head of Head of Quality Management your main responsibilities are as follows :• Implement measures to ensure inspection readiness of Clinical, Pharmacovigilance, Regulatory and Medical activities• Lead Quality Risk Management for Clinical, Pharmacovigilance, Regulatory and Medical activities according to Corporate Risk Management Plan• Lead or support GCP and PV Regulatory Inspections,• Oversee/support the management and escalation of Critical Quality Issues and Serious Breaches• Determine applicable quality standards, regulations and provide guidance and quality oversight• Establish and improve quality systems in Clinical and Pharmacovigilance Quality Assurance• Ensure timely planning and execution of risked based CQA- PVQA audit programs• Ensure the interface between CQA/PVQA team and key stakeholders• Manage a team of Quality Specialists / Managers / Team Leader• Ensure relations with professional external networks for a permanent benchmark on market practices To carry out this mission, we are looking for a Clinical and Pharmacovigilance Quality Assurance Senior Manager bringing the following profile:• University degree in health sciences or related field• Similar position in pharmaceutical industry and/or CRO (ideally min 10 years)• Extensive understanding of interpretation for FDA, EU, CFDA, Russia and ICH regulations (GCP)• Ability to manage a team of Quality Specialists / Managers / Team Leader• Successful collaboration with functions in the clinical and pharmacovigilance quality area• Fluent in English and French• Strong experience of planning, managing and executing PV and GCP audits You are a rigorous person and autonomous in your work. Endowed with an entrepreneurial spirit, you know how to manage different cross functional stakeholders. You like to take a step back to analyze situations and propose new strategies You define yourself as a solution-oriented and methodical person who drives novelty. Thanks to your communication skills, entrepreneurship, and strong team spirit, you integrate quickly into a new environment and easily establish collaborative links with other departments. Are you interested in this opportunity? Apply now and join OM Pharma!
Senior Pharmacovigilance Quality Assurance Auditor
Galderma S.A., La Tour-de-Peilz, Riviera-Pays-d'Enhaut
Senior Pharmacovigilance Quality Assurance Auditor Apply Now Job Family Pharmacovigilance City La Tour-de-Peilz Region Vaud Country Switzerland Contract Type Posting Start Date 17-Sep-2021 Company Overview Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com Job Description Reporting to the Pharmacovigilance Quality Assurance Manager, Senior PV QA Auditor ensures the deployment and execution of the Quality Management System (QMS) dedicated to Galderma Pharmacovigilance, in line with the global strategy and objectives. This role oversees Galderma PV projects worldwide including activities carried out by Global Pharmacovigilance, affiliates, and external partners across the three Galderma product categories (drugs, cosmetics, and medical devices). Job Responsibilities Develop and execute the annual audit program dedicated to Galderma Pharmacovigilance systems, processes, and activities: Perform internal audits related to PV systems and processes, Conduct external audits (affiliates and external partners) of Galderma PV stakeholders, Perform PV subcontractor audits and periodically evaluate their quality level with regards to Galderma PV requirements and applicable regulations and coordinate the qualification of external PV partners e.g. through qualification questionnaire, Write Audit reports according to applicable procedures and review proposed Corrective and Preventive Actions as applicable, Perform peer review of PV QA audit reports. Ensure inspection readiness of the PV Quality Management System (Corporate, Affiliates and external partners when required) including preparation, support and follow up of inspections conducted by Competent Authorities Carry out independent review of PV documentation (including independent review of the PSMF) Contribute to the quality training of PV employees by developing training materials or facilitating training Author or provide input to PV Quality documentation, such as procedures, instructions, and forms Participate to the quality reviews of the PV quality system including the analysis of Key Performance Indicators to identify trends and signals Support Corporate PV in the investigation of deviations related to PV processes and provide quality input into the development of CAPA plans Ensure appropriate documentation of any non-compliance impacting the PV System in an electronic Quality Management System (Trackwise) Review and/or approve PV Quality documentation (compliance review) Foster a PV quality culture in Corporate and Affiliates organizations’ by providing advice from a PV quality perspective University Degree in Life Sciences with a background in Pharmacovigilance and Quality Assurance 10 years of experience in Pharmacovigilance and Quality Management function in a global pharmaceutical company Experience as a Lead Auditor conducting PV Audits of third parties and affiliates Ability to support international projects complying with quality requirements Thorough knowledge of cGVP and global regulatory requirements Ability to work in a matrix organization with an exposure to cross-functional projects Proficient in QMS and Document Management Systems Medical Devices experience is a plus Team player with a collaborative attitude Excellent organization and time management skills Continuous improvements mindset – ability to propose improvements and new solutions Self-motivated and comfortable in fast-paced company environment Strong interpersonal and communication skills Receive the newsletter and learn more about our pioneering work within skin innovation or follow us on Social Media for current news and patients stories
Pharmacovigilance Quality Management Lead
Vifor Pharma Management Ltd., Zürich
Pharmacovigilance Quality Management Lead Vifor Pharma is experiencing rapid pipeline optimization and growth in Nephrology, Cardio-Renal and Rare diseases. A position has arisen in the Pharmacovigilance Quality Assurance (GPvP) group in a leadership role to manage a talented team of PV Quality Auditors and take responsibility for all PV Quality Assurance related topics within the wider Clinical and PV Quality group. You will be an experienced professional within PVQA or an experienced PV Operations professional with significant exposure to PVQA as part of your role. On offer is the opportunity to work within a growth pharmaceutical company with significant pipeline and commercial product and shape the capabilities of a small group of PV auditors to provide your main stakeholders with high confidence levels in a highly regulated sector. Responsibilities Manage the further development and implementation of a risk-based global PV Audit program (including audits of Affiliates, Distributors, Contractors, special programs and systems) in support of clinical safety and Pharmacovigilance activities related to Vifor products. Manage a robust Pharmacovigilance quality system at Vifor Pharma Monitor and assess global safety processes and procedures for consistency and compliance with global laws, regulatory requirements and Vifor policies and procedures. Provide guidance and expert advice and act as point of contact in relation to interpretation of PV regulations, quality improvement, process and program initiatives and risk assessment for the Global Drug Safety Department (GDS) and all other stakeholders (Medical Affairs, Regulatory Affairs, Clinical Development, etc.) which are impacted by Good Pharmacovigilance Practices (GPvP). Lead the preparation, hosting and follow up of Regulatory Authorities inspections related to Pharmacovigilance activities at Vifor Pharma, including Affiliates. Monitor deviations at Global drug safety, escalate as necessary and maintain CAPA oversight for all audits and Inspections. Generate and provide metrics, status and trend reports and other information, as required by management Sound knowledge of worldwide regulations pertaining to GPvP for pharmaceutical products Knowledge and experience in auditing Knowledge of quality management systems University degree or equivalent in health sciences, nursing, pharmacy or related field 2 to 5 years plus experience in PV auditing with EU/FDA /global regulatory requirements Minimum 5 years’ experience in the pharmaceutical industry Willingness to travel (approx. 25 %). Preferred Requirements Experience in drug safety operational / medical role Knowledge regarding the use of electronic systems in a regulated environment Knowledge of drug development process within a regulatory environment. About Us The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
Senior Pharmacovigilance Manager 100%
AurigaVision, Basel, Basel-Stadt
Our customer is a multinational pharmaceutical company with a wide portfolio in specialty medicines and OTC products. For the offices in Basel, we are looking for a Senior Pharmacovigilance Manager 100% Basel In this role you will be responsible for the local pharmacovigilance system in close collaboration with the global pharmacovigilance organization of the company. We are looking for someone with profound experience of Swiss regulations and the motivation to renew the local organization and processes. Your main responsibilities Overseeing and conducting the routine pharmacovigilance tasks in an affiliate Case processing (collection, global database entry, QC, follow-up and submission) Collaborating with Regulatory Affairs on submission of PSURs and RMPs and implementation of CCSI Developing pharmacovigilance activities and risk minimization activities for the company’s products, agreeing them with Swissmedic and ensuring their implementation Responsible for developing and maintaining local pharmacovigilance agreements Coordination of Health Hazard Assessments Reconciliation activities CAPA management Responsible for pharmacovigilance compliance with Swiss regulations and local SOPs, also for external contractual partners, including training and SOP maintenance Main contact for Swissmedic on all pharmacovigilance matters Representing drug safety and providing relevant inputs in local projects and activities Leading the Local Pharmacovigilance team, including budget responsibility Your Qualifications Master degree in life sciences, pharmacist, or health science professional degree At least 5 years’ experience in Swiss pharmacovigilance, mainly in pharmaceutical industry Profound knowledge and understanding of Swiss regulations with regard to pharmacovigilance practices Very good knowledge of ICH (GCP) and EU Good Pharmacovigilance Practice (GVP) Fluency in English and German is a must, language skills in French and/or Italian is a strong plus You are detail oriented showing a high level of responsibility and accuracy You are a team player with strong communication skills Regina Kolb is looking forward to receiving your application Full discretion is guaranteed and we will gladly answer any additional questions.
Sr Manager QA Pharmacovigilance
Incyte Corporation, Morges
SUMMARY The Sr Manager QA PhV will play lead role in the oversight and assessment of GVP activities to ensure robust systems and processes for global Pharmacovigilance activities. This position is responsible for providing Pharmacovigilance (PhV) audit support for QA management and oversight from QA aspect of global PhV activities of various teams within lncyte (Global PV departments, Clinical Development teams and others relevant departments/function with pharmacovigilance activities) to the Head of lncyte Global QA Clinical and PhV. This job will include the execution and management of lncyte QA PhV/GCP audits and the provision of PhV /GCP guidance and advice across relevant Post-marketing and Clinical Development areas. DUTIES AND RESPONSABILITIES Lead the establishment, maintenance and execution of the GPvP audit program (Processes, affiliates, vendors, business partners and all others relevant structures/functions identified). Lead the maintenance of the PhV Quality Management System including QA support for PhV supplier qualification, risk management, change control, deviations, review of SOPs with ensuring continuous process improvement Establish robust collaboration with PhV Leaders, including EU-QPPV. Reviewing key pharmacovigilance documents, e.g. PSMF, reports, and regulatory submissions. Assist in preparing, coordinating and hosting Inspections/Partner audits in collaboration with the PhV function. Support the development of the PhV training program in collaboration with PhV group. Coordinate responses and corrective/preventative actions from deviations, audits and regulatory inspection findings. QA PhV and Clinical global: Stay abreast of Pharmacovigilance and Safety regulations, EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate. Escalate to Global QA Clinical/PhV Management of internal and external serious non-compliance/deviations in a timely manner. Provide support for regulatory authority inspections including conducting pre-inspection audits and inspection readiness activities as assigned. Assist with the management of QA consultants performing audits on behalf of lncyte Corporation. Foster a relationship of trust and effective communication with functional stakeholder Be knowledgeable with assigned lncyte compounds and protocols, and be able to understand advanced operational, scientific and/or medical problematic REQUIREMENTS Minimum Bachelor's degree in a science or healthcare related discipline, or similarly conferred degree from a University 3 - 10 years' experience in a pharmaceutical or bio-pharmaceutical company in a PV QA role with a minimum of 2 years’ lead auditor experience performing GVP compliance audits of vendors and business partners. Ability to travel a minimum of 30%. Prior GVP I GCP inspection experience preferred. Thorough knowledge in cGCP and cGVP and global regulatory requirements; Experience in managing Audit contractors Strong Interpersonal skills, including organizational sense, rational and autonomy Strong verbal and written communication skills with well-structured communication and presentation ability; English fluency written and spoken (the company language); Knowledge of other languages such as French is an asset; Results focused which may require negotiating skills and diplomacy, Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here . You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte’s data protection practices here . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). Please contact privacyincyte.com if you have any questions or concerns or would like to exercise your rights.
Senior GCP Strategy Lead
Roche, Basel, CH
We have an exciting GCP Quality Lead opportunity in our GCP Strategy group at Roche PDQ. Do you believe that Quality Assurance can be more than simply the conduct of audits and can bring vital medicines to patients faster? The mission of Roche Product Development Quality is to achieve Unrivaled Transparency with health authorities so that our medicines are brought to patients safely and quickly. We instill confidence that our non-clinical, clinical, pharmacovigilance and computerized systems activities comply with regulations and guidelines. We Partner with internal functions, process owners and study teams to provide a quality framework that protects patient safety and the company’s lic
Patient Safety & Distributor Markets Senior Manager
Modis, Neuchatel, Switzerland
Patient Safety & Distributor Markets Senior ManagerWe are recruiting, on behalf of our client, a Patient Safety Senior Manager. You will join the International Patient Safety Group. The Patient Safety Group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. Contractor 1 year Responsibilities Leadership · Holds responsibility for oversight of all Patient Safety activities performed by the Distributor · Plans, develops and communicates local WWPS strategy and expected operationalization to Distributor on safety related activities (including for example RM activities, HA connectivity, contracts and quality management issues) so as to meet agreed performance · Liaises with Distributor and Leads and represents the Company on safety related matters with the Health Authority and external partners/organisations such as industry associations, and actively participates in negotiations and discussions on safety related topics. · Ensures oversight of agreed Distributor KPI in collaboration with QST · Maintain a strong and open relationship with cross-functional stakeholders related to: the provision of guidance on pharmacovigilance requirements, to ensure compliance of the Distributor and safety related considerations are analysed, evaluated and resolved as necessary · Represents the LR country in collaboration with Regional and Global patient safety teams to build effective and efficient working practices. · Utilizes an effective decision-making process, demonstrates strong judgment, decisiveness and ability to balance the operational and strategic needs thereby enhancing the success of BMS in collaboration with global stakeholders. · Supervisory responsibilities as line manager as required Compliance · Endorse and implement a culture of compliance, act as a role model demonstrating consistent ethical and professional behaviour · Collaborate with Distributor as necessary on audit/inspection readiness and supports cross-functional teams in collaboration with quality stakeholders to ensure effective conduct of audits/inspections for Distributors Profile: · University degree (preferably health or life science) or nursing qualification · ? 5 years in the Pharmaceutical Industry, usually with at least 3-5 years’ experience working in Pharmacovigilance or in a closely aligned field in the respective country(ies) · Line management experience · Strong leadership and Coordination capability · Ability to build effective working relationships with cross-functional teams · Ability to develop excellent working relationship with the local HA or country HA liaison group/body where such opportunities exist. Positively contributes to the shaping of patient safety within the local market through interactions with the HA and relevant professional associations. · Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding safety risk related requirements internally (local/regional/HQ) and externally (HAs, BPs). · Strong understanding of GxP and expert knowledge of local and global regulations · Has a clear understanding of the broader impact and possible implications on processes/the environment. · Demonstrated ability to negotiate difficult safety/compliance issues and influence internal and external partners.