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Pharmacovigilance Director
2 months ago
About the Role
We are seeking a highly skilled and experienced Pharmacovigilance Director to join our Medical Scientific Unit (MSU) team at Tevapharm. As a key member of our team, you will play a critical role in ensuring the safety of our innovative products throughout their lifecycle.
Key Responsibilities
- Lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post-marketing.
- Perform medical review and assessment of Individual Case Safety Reports (ICSRs) for assigned products from clinical trials.
- Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products, including signal detection and evaluation, dose escalation evaluations, regulatory safety reports, and ad-hoc safety reviews/assessments.
- Perform signal management activities such as signal validation, authoring of complex signal evaluations, and signal evaluation review.
- Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and management of these plans throughout the product's lifecycle.
- Perform due diligence on product safety profile of potential new assets.
- Minimum 3 years of working experience in pharmacovigilance and drug safety area as a safety physician, including experience in managing safety issues in pre- or post-marketing environments.
- Excellent communication skills in speaking and writing English.
What We Offer
- 25 days of annual leave, pension scheme, company car or car allowance.
- Life and Critical Illness Insurance, Private health insurance for you and your family, Sports and Health Programme.
- Recognition programs to reward our employees with our company bonus scheme.
- Well-being and Diversity and Inclusion focused company.
Reports To
MSU Team Leader (based in USA).
Tevapharm's Equal Employment Opportunity Commitment
Tevapharm is committed to equal opportunity in employment.
