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    Director Global Pharmacovigilance - Safety Physician

    Teva Pharmaceuticals
    5+ years
    Not Disclosed
    Madrid
    10 Nov. 30, 2024
    Job Description
    Job Type: Full Time Education: MD/DO/PhD 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: Director, Global Pharmacovigilance - Safety Physician

    Location: Madrid, Spain (Flexible - can be based in any European country where Teva has offices)
    Company: Teva Pharmaceuticals
    Job ID: 58386
    Date: Nov 20, 2024

    About Teva Pharmaceuticals

    Teva Pharmaceuticals is a global leader in the generic medicines sector and the proud manufacturer of products on the World Health Organization’s Essential Medicines List. Our mission is to make health more affordable and accessible worldwide. With operations across nearly 60 countries, Teva serves over 200 million people every day, improving their health through essential medicines.

    The Opportunity

    Teva is seeking a Safety Physician for the Director of Global Pharmacovigilance role within its Medical Scientific Unit (MSU). This individual will be responsible for overseeing safety profiles of Teva products in clinical development and supporting safety throughout the product lifecycle. In partnership with other stakeholders, the Safety Physician will help define risks and propose measures to minimize them, ensuring a maximized benefit-risk ratio for Teva drugs.

    Key Responsibilities

    • Safety Profile Management: Lead safety strategies for assigned products during clinical development and throughout the product lifecycle, including Company-Sponsored studies, Investigator-Sponsored studies, Compassionate Use, and Disease Monitoring Programs.
    • Collaboration with R&D Teams: Work with cross-functional teams to execute safety strategies and contribute to clinical documents such as protocols, clinical study reports, regulatory submissions (e.g., CTD, PSUR, PADER), and other safety-related documents.
    • Leadership: Lead and chair the Product Safety Group, presenting decisions to senior governance committees and top management.
    • Medical Review & Signal Detection: Perform medical reviews of Individual Case Safety Reports (ICSRs) and interpret aggregate safety data, including signal detection and regulatory safety reports (e.g., PSURs).
    • Risk Management: Lead Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and oversee their management throughout the product’s lifecycle.
    • Product Labeling: Represent Pharmacovigilance in the Product Label Working Group, ensuring that safety-related sections of the product label are appropriately developed and updated.
    • Training & Support: Provide guidance and training to Pharmacovigilance scientists on safety surveillance activities, including signal detection and risk evaluation.
    • Cross-functional Collaboration: Collaborate with Medical Affairs, Clinical Development, Quality, KOLs, and CROs to communicate safety concerns and the overall safety profile of products.
    • Global Launch Support: Support global product launches and due diligence on the safety profiles of potential new assets.

    Qualifications and Experience

    • Education: MD or equivalent. Completion of an accredited Residency/Specialty program and Board Certification or Eligibility.
    • Experience:
      • Minimum 5 years of experience working in pharmacovigilance and drug safety as a safety physician.
      • Experience in drug development in therapeutic areas such as immunology or neurology is a plus.
      • Familiarity with FDA and EMA regulations (e.g., GVP, GCP).
      • Experience with NDA/BLA submissions in the US and MAA submissions in Europe.
      • Proven experience in managing safety issues in pre- and post-marketing environments.
      • Strong background in leading safety surveillance tasks and chairing safety committee meetings.
    • Skills:
      • Ability to work cross-functionally with international teams across multiple time zones.
      • Excellent communication skills (both spoken and written) in English.
      • Ability to lead and collaborate with multiple stakeholders in a complex global environment.

    Reports To

    • Sr Dir MSU Team Leader

    What Teva Offers

    • Opportunity to contribute to global safety strategies for Teva’s portfolio.
    • Work with cross-functional teams to drive safety in drug development.
    • Flexible location across Teva's European offices.
    • Competitive compensation and benefits package.
    • A dynamic, inclusive work environment focused on growth and learning.

    Teva Pharmaceuticals is an Equal Opportunity Employer, committed to diversity and inclusion. We ensure equal opportunities without regard to age, race, creed, religion, gender, or any other legally protected status. If you require accommodations during the recruitment process, please inform us so we can support you.

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