Head of Pharmacovigilance

☞ Agomab

Aussicht: 103

Update Tag: 16-11-2025

Ort: Antwerp City Antwerp

Kategorie: R & D IT - Software

Industrie: Biotechnology Research

Jobtyp: Full-time

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Jobinhalt

Department:Clinical Development

Location:Agomab All Sites

Description

We are looking for a Head of Drug Safety and Pharmacovigilance to expand our Clinical Development team. In this role you will report to the Chief Medical Officer and will be responsible for the overall risk management and safety strategy of the Company’s product pipeline.

Key Responsibilities

  • As the Head of the Drug Safety and Pharmacovigilance function, provide leadership and strategic direction for the Company’s Drug Safety function;
  • Assess and develop internal and external resources and processes to ensure compliance with all relevant drug safety and pharmacovigilance regulations, including those of the FDA, EMA, and other regulatory bodies;
  • Ensure the implementation and maintenance of effective quality systems for drug safety operations;
  • In collaboration with regulatory and clinical development, establish the safety strategy, core safety information, safety reporting, benefit-risk evaluation, and risk management strategies for all Company assets, from clinical development to post-approval safety surveillance;
  • Participate in publication preparation and medical information material review;
  • Manage medical aspects of aggregate data analysis, presentation of medical analyses internally and to regulatory agencies as required, expedited case analyses, and ensure the signal management and risk management functions of the contract service organizations meet corporate goals and key performance indicators;
  • Supports ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintains audit trail as inspection ready at all times.

Skills, Knowledge And Expertise

  • You have a Medical Doctor degree;
  • 10+ years of drug safety and pharmacovigilance experience in biotechnology and/or pharmaceutical industry, with 3+ years of experience in senior oversight of a drug safety and pharmacovigilance function;
  • Extensive experience with all aspects of safety signal evaluation, including data review and analysis, collaboration with cross-functional team members and senior management, authoring required regulatory correspondence;
  • Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews;
  • Management of compliance deviations and formulations of CAPAs.

Benefits

  • The opportunity to develop pioneering science in a young biotech company;
  • Challenging and innovative work environment as part of a driven team;
  • Flexibility and responsibility based in Boston with remote working options that can be tailored for you;
  • Competitive salary and benefits;
  • An agile and fast paced environment.
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Frist: 31-12-2025

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