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Associate Director, Pharmacovigilance Safety (Fixed-Term Contract)

3+ years
Not Disclosed
-10 April 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Job Title: Associate Director, Pharmacovigilance Safety (Fixed-term contract)

Date: April 9, 2025
Location: Bucharest, Romania, 050713
Company: Teva Pharmaceuticals
Job ID: 57908

Who We Are:
Teva is a global pharmaceutical leader and the world's largest producer of generic medicines, dedicated to improving health and increasing access to quality healthcare solutions. With a presence in over 80 countries, Teva delivers an extensive portfolio of products to 200 million people daily. Our success is driven by our employees and a promising pipeline focused on core therapeutic areas, patient-centric solutions, and continuous growth in both generic and specialty medicines. Learn more at
www.tevapharm.com.

The Opportunity:
As an Associate Director, Pharmacovigilance Safety Physician, you will lead activities crucial for determining the safety profile and managing the risks of assigned products throughout their lifecycle, ensuring comprehensive safety information is provided to patients, prescribers, and regulators.

How You’ll Spend Your Day:

  • Conduct medical evaluation and interpretation of aggregate safety data for assigned and non-assigned products, including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety assessments.

  • Review complex Health Hazard Assessments and Health Authority requests.

  • Perform signal management activities such as signal validation quality control, authoring, and reviewing complex signal evaluations.

  • Support risk management activities by contributing to Risk Management Plans (RMPs), REMS, and the design and management of additional risk minimization measures.

  • Represent Pharmacovigilance (PV) in cross-functional Product Label Working Groups, contributing to the development and maintenance of the Company Core Safety Information (CCSI) and regulatory negotiations.

  • Provide PV support and safety contributions for Health Authority submissions and due diligence processes.

  • Collaborate cross-functionally with internal teams (Medical Affairs, Clinical Development, Quality) and external stakeholders (KOLs, CROs), ensuring strong representation of PV positions on safety matters.

Your Experience and Qualifications:

  • Medical Doctor (MD) degree.

  • Clinical practice experience and/or training in epidemiology.

  • Minimum of 3 years’ experience working in pharmacovigilance and drug safety as a safety physician.

  • Proven ability to manage safety surveillance tasks and lead safety committee meetings.

  • Expertise in serving as a subject matter expert (SME) in pharmacovigilance.

  • Excellent communication skills with an ability to collaborate across departments and influence stakeholders without direct authority.

  • Strong capability to work in an international, matrixed team across multiple time zones.

  • Fluency in English, both oral and written.

Already Working @Teva?
Current Teva employees should apply via the internal career site available on "Employee Central" to be prioritized and access internal-only opportunities. If assistance is needed with EC account access, employees should contact their local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to equal employment opportunities without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally protected status. We are dedicated to fostering a diverse and inclusive workplace. Candidates requiring accommodation during the recruitment process should inform us; all information will be treated confidentially to ensure an accessible experience.