Associate Director, Pharmacovigilance Safety (Fixed-term Contract) - 57908
Company: Teva Pharmaceuticals
Location: Bucharest, Romania, 050713
Date: March 11, 2025
Who We Are:
Teva Pharmaceuticals is a global pharmaceutical leader and the world's largest producer of generic medicines, committed to enhancing health and increasing access to quality health solutions worldwide. With a workforce across 80+ countries, Teva delivers the world’s largest medicine cabinet to 200 million people daily. We offer a diverse product portfolio and continue to grow both our generic and specialty medicines business through investment in research, development, marketing, and innovation.
The Opportunity:
As an Associate Director, Pharmacovigilance Safety Physician, you will oversee activities necessary to determine the safety profile and mitigate risks for assigned products throughout their lifecycle. You will ensure comprehensive safety information is available to patients, prescribers, and regulatory authorities.
How You’ll Spend Your Day:
Accountable for medical evaluation/interpretation of aggregate safety data for assigned and non-assigned products, including signal detection, dose escalation evaluations, and regulatory safety reports (PSUR, PADER, DSUR).
Review complex Health Hazard Assessments and respond to Health Authority requests.
Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation reviews.
Support risk management activities globally, including the preparation of Risk Management Plans (RMPs), REMS, and the design of risk minimization measures throughout the product lifecycle.
Represent PV in cross-functional Product Label Working Groups and oversee safety-related sections of product labels, including initial development and ongoing updates.
Provide PV support and safety contributions for Health Authority submissions and responses.
Collaborate effectively with internal (Medical Affairs, Clinical Development, Quality, etc.) and external stakeholders (KOLs, CROs) to ensure a unified safety strategy and address safety concerns.
Your Experience and Qualifications:
Education: Medical Doctor degree.
Experience:
Minimum 3 years of experience as a safety physician in pharmacovigilance and drug safety.
Clinical practice experience and/or epidemiological degree/training is preferred.
Proven ability to manage safety surveillance tasks and chair safety committee meetings.
Expertise as a subject matter expert in safety and risk management.
Skills:
Outstanding communication and collaboration skills with the ability to influence others without direct authority.
Ability to work cross-functionally within a matrix/international team across multiple time zones.
Oral and written fluency in English.
Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is dedicated to providing equal employment opportunities regardless of age, race, creed, religion, sex, disability, medical condition, sexual orientation, gender identity, national origin, or any other legally recognized status. We are committed to fostering a diverse and inclusive workplace.
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