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Director Global Pharmacovigilance - Safety Physician

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 | Harlow, United Kingdom
📍 Location: Harlow, United Kingdom (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 generic medicines, working with a mission to make health more affordable and accessible. With its dedication to producing life-changing medicines, Teva reaches millions of people globally and is proud of its significant contribution to the World Health Organization’s Essential Medicines List.

Role Overview

The Safety Physician - Director Global Pharmacovigilance will oversee the safety strategy and risk management for Teva’s drug portfolio, leading safety initiatives across the product lifecycle. This includes working closely with R&D teams and regulators to ensure product safety, managing safety concerns, and driving risk management activities for assigned products.

Key Responsibilities

Lead Safety Profile: Manage the safety profile of assigned products through clinical development and work with cross-functional teams to ensure execution of safety strategies.
Medical Review: Perform medical reviews of Individual Case Safety Reports (ICSRs) from clinical trials.
Risk Management: Lead and manage global Risk Management Plans (RMPs) and REMS throughout a product’s lifecycle.
Regulatory Reports: Responsible for interpreting and evaluating safety data and producing regulatory safety reports like PSUR, PADER, DSUR, and more.
Cross-Functional Collaboration: Represent PV in product label working groups, safety-related negotiations with regulatory bodies, and contribute to product labeling strategies.
Training and Support: Provide guidance and support to PV scientists involved in safety surveillance tasks like signal detection and risk evaluation.
Launch Support: Aid in global launch activities and carry out due diligence on new product assets for safety evaluations.

Qualifications

🎓 Education:

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

💼 Experience:

  • 5+ years of experience 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)
  • Familiarity with NDA/BLA submissions (US) and MAA (Europe)
  • Experience in managing safety surveillance tasks and chairing safety committees

Desired Skills

  • Excellent communication skills in both speaking and writing English.
  • Ability to work cross-functionally with international teams across multiple time zones.
  • Proven ability to handle safety issues in both pre and post-marketing environments.

Reports To

Sr Dir MSU Team Leader

Teva’s Equal Employment Opportunity Commitment

Teva is committed to equal opportunity in employment, embracing a diverse and inclusive workplace for all candidates.

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