Job Title: Director, Pharmacovigilance Safety Physician
Location: Bucharest, Romania
Company: Teva Pharmaceuticals
Job ID: 56387
Date: Nov 28, 2024
About Teva Pharmaceuticals
Teva is the world's largest producer of generic medicines and a global leader in the pharmaceutical industry. We are committed to improving global health by providing access to quality, affordable medicines. Our diverse portfolio serves 200 million people every day, and we are actively investing in research, development, and innovation to improve health outcomes. We continue to grow in both the generic and specialty medicines sectors and are dedicated to delivering patient-centered solutions.
The Opportunity
Teva is seeking a Director, Pharmacovigilance Safety Physician to lead the safety activities for assigned products throughout their lifecycle. The role will be responsible for monitoring, mitigating risks, and providing comprehensive safety information to patients, prescribers, and regulators.
Key Responsibilities
Safety Profile Management:
Lead the medical evaluation of safety data for assigned and non-assigned products, including signal detection, dose escalation evaluations, and preparation of regulatory safety reports (e.g., PSUR, PADER, DSUR).
Review complex Health Hazard Assessments and respond to Health Authority requests.
Signal Management:
Perform signal validation, author complex signal evaluations, and manage signal evaluation activities.
Assess causality, consolidate safety data, and determine if a signal qualifies as a risk.
Risk Management:
Contribute to the development of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and additional risk minimization measures throughout the product lifecycle.
Define important risks, potential risks, and missing information for assigned products.
Cross-Functional Collaboration:
Represent Pharmacovigilance in the Product Label Working Group, ensuring safety-related sections of the product label are properly evaluated and negotiated with regulatory agencies.
Collaborate with internal (e.g., Medical Affairs, Clinical Development, Quality) and external stakeholders (e.g., KOLs, CROs) to communicate the safety profile of products and ensure the effective execution of safety strategies.
Health Authority Submissions:
Provide safety contributions for Health Authority submissions and responses.
Represent pharmacovigilance during due diligence activities for potential products.
Qualifications and Experience
Medical Doctor degree or equivalent.
Clinical practice experience and/or epidemiological training.
A minimum of 5 years’ experience in pharmacovigilance and drug safety, particularly as a safety physician.
Proven ability to handle safety surveillance tasks, chair safety committee meetings, and serve as a subject matter expert.
Strong communication skills with the ability to collaborate with various departments and influence others without direct authority.
Ability to work within a matrix team, across multiple time zones.
Fluency in English (both oral and written).
Reports To
Sr Dir, Pharmacovigilance
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is an equal opportunity employer, committed to diversity and inclusion in the workplace. We provide equal employment opportunities regardless of age, race, creed, religion, sex, disability, or any other legally protected status. If you require accommodations during the recruitment process, please let us know.
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