Job Title: Senior Manager (m/f/d) Pharmacovigilance 100%
Location: Basel, Switzerland
Company: Teva Pharmaceuticals
Job ID: 59042
Date: Nov 4, 2024
About Mepha and Teva in Switzerland
Mepha Pharma AG and Teva Pharma AG are leading pharmaceutical companies in Switzerland, with a strong presence since 2011 when Mepha became part of Teva Group. Together, they offer a portfolio of over 320 products across various therapeutic areas, including generics, biosimilars, and innovative medicines for CNS, respiratory, and oncology conditions. With over 174 employees, Teva and Mepha are one of Switzerland's largest suppliers of medicines.
The Opportunity
The Senior Manager Pharmacovigilance will oversee routine pharmacovigilance tasks for the Swiss affiliate, working closely with both regional and global pharmacovigilance teams. This includes handling case processing, ensuring regulatory compliance, managing risk minimization activities, and maintaining strong relationships with Swiss regulatory authorities such as Swissmedic.
In addition to managing the local pharmacovigilance responsibilities, you will lead specific PV DACH (Germany, Austria, Switzerland) topics, ensuring compliance with both local and global regulations, and act as a subject matter expert in the region. You will also lead the local PV team and manage departmental activities including budgets.
Key Responsibilities
Pharmacovigilance Compliance: Ensure compliance with Swiss regulations for pharmacovigilance, including PSURs, RMPs, CCSI, and signal management.
Case Processing: Oversee the collection, QC, follow-up, and submission of safety cases to global databases.
Regulatory Collaboration: Work with Regulatory Affairs to submit safety reports to Swissmedic and coordinate risk minimization activities.
Local Agreements: Develop and maintain local pharmacovigilance agreements with Swiss regulatory authorities and partners.
Health Hazard Assessments: Lead Health Hazard Assessments and conduct reconciliation activities.
CAPA Management: Handle CAPA (Corrective and Preventive Action) management.
Team Leadership: Lead the local PV team, ensuring all members are properly trained and meet performance expectations. Manage the team budget.
DACH Region Leadership: Act as a subject matter expert for pharmacovigilance activities across the DACH region (Germany, Austria, Switzerland), ensuring compliance with global standards.
Swissmedic Liaison: Serve as the main point of contact for Swissmedic on all pharmacovigilance-related matters.
Cross-functional Collaboration: Collaborate with other Teva affiliates and external stakeholders to ensure smooth pharmacovigilance operations.
Regulatory Updates: Stay current on regulatory changes in pharmacovigilance to ensure continuous compliance and process improvement.
Project Participation: Represent pharmacovigilance in local projects, ensuring drug safety considerations are incorporated.
Qualifications & Experience
Education: Master’s degree in Life Sciences, Pharmacy, or Health Sciences.
Experience:
Minimum 5 years of experience in pharmacovigilance, with significant exposure to the Swiss pharmaceutical industry.
Profound knowledge of Swiss pharmacovigilance regulations and EU Good Pharmacovigilance Practices (GVP).
Strong understanding of ICH (International Council for Harmonisation) and Good Clinical Practice (GCP).
Languages:
Fluency in English and German is required.
Knowledge of Italian and/or French is a strong plus.
Leadership: Experience in team leadership is preferred.
Skills:
Proficient in Microsoft Office (Excel, Word, PowerPoint).
Strong communication skills, with the ability to work in a matrix organization.
Ability to balance responsibility, flexibility, and accuracy in a fast-paced, multitasking environment.
What We Offer
Dynamic Role: A challenging and varied role with international scope in a growing organization.
Career Development: Opportunities to grow within a global leader in generics and pharmaceuticals.
Work-Life Balance: Enjoy benefits such as a lunch card and public transport allowance.
Convenient Location: Central office near Basel SBB train station, making commuting easy.
Teva Pharmaceuticals is an Equal Opportunity Employer, committed to fostering a diverse and inclusive workplace. If you need accommodations during the recruitment process, please inform us so we can support you.
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