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    Deputy Eu Qualified Person For Pharmacovigilance

    Takeda Pharmaceutical
    10+ years
    Not Disclosed
    Brussels
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Education: M.Pharm/Pharm.D/M.Med/MD/M.BioMed 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 Opportunity: Deputy EU QPPV (Qualified Person for Pharmacovigilance)

    Location: EU/EEA (European Union + Norway, Iceland, or Liechtenstein)
    Company: Takeda

    This leadership position within Takeda involves collaborating closely with the EU QPPV and overseeing compliance with EU and global pharmacovigilance regulations. The role requires ensuring timely and accurate pharmacovigilance operations, regulatory reporting, and oversight of critical safety documentation and systems.

    Key Responsibilities

    Regulatory Compliance and Oversight

    • Serve as a 24-hour pharmacovigilance contact point for EU competent authorities and the European Medicines Agency (EMA).
    • Act as a back-up in the absence or unavailability of the EU QPPV.
    • Ensure compliance with EU Pharmacovigilance System Master File (PSMF) regulations and manage the PSMF team.
    • Oversee Pharmacovigilance Policy Intelligence (PVPI) to maintain alignment with evolving global regulations.
    • Provide expertise in EU/global PV legislation to guide process compliance with regulatory changes.

    Document and Report Management

    • Review and approve critical documents, including:
      • EU PSMF and Risk Management Plans (EU RMP).
      • Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
      • Post-Authorization Safety Studies (PASS) protocols and reports.
      • EU Summary of Product Characteristics (SmPC).
    • Support preparation of regulatory actions in response to emerging safety concerns, such as variations and urgent safety restrictions (USRs).

    Collaboration and Communication

    • Work closely with cross-functional teams, including Regulatory Affairs, Medical Affairs, Clinical, Quality, Manufacturing, and Supply Chain.
    • Collaborate with PSPV functions and external stakeholders during inspections and audits.
    • Participate in and contribute to forums and meetings, such as:
      • PASS Review Meetings.
      • PSMF Forums.
      • EU QPPV Team Meetings.
      • Safety Management Team (SMT) Meetings.

    Leadership and Strategy

    • Provide input into corrective and preventive actions (CAPA) in collaboration with Quality Assurance (QA).
    • Demonstrate leadership in team building, motivating, and mentoring across matrixed environments.
    • Represent the company during pharmacovigilance inspections and audits.

    Qualifications

    Education and Experience

    • Preferred: Medical degree (MD) or professional doctorate in Pharmacy or Sciences (PharmD, MPharm, MMed, MBioMed).
    • At least 10 years of professional experience in pharmacovigilance, with a strong understanding of EU/global PV regulations.
    • Desirable: Experience as an EU QPPV or Deputy EU QPPV.
    • Proven experience with regulatory inspections focusing on pharmacovigilance.
    • Background in international, multi-disciplinary drug development, with exposure to various therapeutic areas.

    Skills and Competencies

    • Strong leadership and management skills.
    • Excellent written, verbal, and presentation communication abilities.
    • Expertise in prioritizing, delegating, and managing multiple critical issues.
    • Knowledge of regulatory expectations, particularly in the EU.
    • Residing and operating in the EU/EEA region is required.

    Why Join Takeda?

    At Takeda, you’ll be part of a diverse, innovative, and patient-centered organization. The company fosters a collaborative workplace culture that prioritizes excellence, inclusion, and equal opportunity.

    If you’re ready to contribute your expertise and leadership in pharmacovigilance at the global level, this is an exciting opportunity. Let me know if you’d like assistance with the application process or preparing your materials!

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