Associate Director, Pharmacovigilance Safety (Fixed-term contract)
Location: Bucharest, Romania, 050713
Company: Teva Pharmaceuticals
Job ID: 57908
Date: April 9, 2025
About Teva Pharmaceuticals:
Teva is a global leader in the pharmaceutical industry and the world’s largest producer of generic medicines. Committed to improving health and increasing access to quality health solutions, Teva serves 200 million people every day. The company continues to grow through investment in research and development, innovation, and a diverse portfolio of products that include both generic and specialty medicines. Teva's global team is at the heart of its success, dedicated to developing patient-centric solutions and creating better, healthier lives.
Role Overview:
Teva is seeking an Associate Director, Pharmacovigilance Safety Physician on a fixed-term contract. In this role, you will be responsible for conducting activities related to the safety profile of assigned products throughout their lifecycle. This includes risk characterization, monitoring, mitigation, and providing comprehensive safety information to patients, prescribers, and regulators.
Key Responsibilities:
Safety Evaluation:
Medical evaluation and interpretation of aggregate safety data, including signal detection, dose escalation evaluations, and regulatory safety reports (e.g., PSUR, PADER, DSUR).
Conduct Health Hazard Assessments and respond to Health Authority requests.
Perform signal management activities such as signal validation QC and authoring complex signal evaluations.
Assess causality and consolidate safety information from different sources to determine if a signal qualifies as a risk.
Risk Management:
Support risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, and additional risk minimization measures.
Manage Risk Management Plans throughout the product lifecycle.
Define important identified risks, important potential risks, and missing information.
Cross-functional Collaboration:
Represent Pharmacovigilance (PV) in the cross-functional Product Label Working Group.
Collaborate with regulatory agencies for safety-related label negotiations and maintenance of the Core Safety Information (CCSI).
Provide PV support to Health Authority submissions and responses.
Collaborate with internal and external stakeholders, including Medical Affairs, Clinical Development, KOLs, and CROs, ensuring the execution of safety strategies.
Qualifications:
Education & Experience:
Medical Doctor degree.
Clinical practice experience or epidemiological degree/training.
Minimum of 3 years of experience working in pharmacovigilance and drug safety as a safety physician.
Skills & Expertise:
Proven ability to handle safety surveillance tasks and chair safety committee meetings.
Subject matter expertise in pharmacovigilance.
Excellent communication skills and ability to collaborate cross-functionally with various departments.
Ability to work in a matrix/international team across multiple time zones.
Fluent in both oral and written English.
Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals offers equal employment opportunities to all applicants, without regard to age, race, gender, disability, or other protected statuses. The company is committed to diversity and inclusion, ensuring accessible candidate experiences throughout the recruitment process.
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