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Director Global Pharmacovigilance - Safety Physician 1

5+ years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: MD 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

📌 Director Global Pharmacovigilance - Safety Physician 1 | La Défense Cedex, France
📍 Location: La Défense Cedex, France (Can be based in any European country with Teva offices)
💼 Company: Teva Pharmaceuticals
🕒 Experience: 5+ years in pharmacovigilance and drug safety

About Teva Pharmaceuticals

Teva Pharmaceuticals is a global leader in the production of generic medicines and is committed to making health more affordable and accessible to people worldwide. With a mission to improve lives, Teva serves millions of patients globally, producing products on the World Health Organization’s Essential Medicines List.

Role Overview

The Safety Physician - Director Global Pharmacovigilance will lead safety strategies and oversee the risk management activities for Teva's portfolio. This includes managing the safety profile of assigned products during clinical development and post-marketing, collaborating with various R&D teams, and driving safety-related decisions across multiple platforms.

Key Responsibilities

Lead Safety Profile: Manage the safety profile of assigned products during clinical development and collaborate with R&D teams to ensure the execution of safety strategy.
Medical Evaluation: Conduct medical reviews of Individual Case Safety Reports (ICSRs) from clinical trials.
Risk Management: Lead global risk management activities for assigned products and contribute to the preparation of Risk Management Plans (RMPs) and REMS.
Regulatory Reports: Accountable for medical evaluation of aggregate safety data, including signal detection and evaluation, and regulatory safety reports such as PSUR, PADER, and DSUR.
Cross-Functional Collaboration: Represent PV in cross-functional teams and product label working groups, and contribute to product labeling negotiations with regulatory agencies.
Training and Mentoring: Provide support, training, and guidance to PV scientists on safety surveillance tasks, including signal detection and risk evaluation.
Support Launch: Assist in global launch activities and perform due diligence on new product assets.

Qualifications

🎓 Education:

  • MD or equivalent degree
  • Completion of an accredited Residency/Specialty program and Board Certification (or eligibility)

💼 Experience:

  • 5+ years working in pharmacovigilance and drug safety as a safety physician
  • Experience in immunology or neurology therapeutic areas is a plus
  • Strong knowledge of FDA and EMA regulations (GVP, GCP)
  • Experience with NDA/BLA submissions (US) and MAA (Europe)
  • Proven ability to lead safety committees and manage safety issues in both pre- and post-marketing environments

Desired Skills

  • Strong cross-functional collaboration skills and experience working with international teams across multiple time zones.
  • Excellent communication skills in both speaking and writing English.

Reports To

Sr Dir MSU Team Leader

Teva’s Equal Employment Opportunity Commitment

Teva is committed to providing equal employment opportunities and fostering a diverse and inclusive workplace.

📩 Apply Now