Global Safety Lead for Pharmaceutical Products

hace 2 semanas


Bogotá, Bogotá D.E., Colombia Biom?Rieux Bv A tiempo completo

**Job Description**

The Global Safety Lead for Pharmaceutical Products will support the Clinical Safety and Risk Management team in the safety surveillance of assigned products. Proficient in retrieval, data preparation, and preliminary analysis for, and quality assurance of, prepared responses to inquiries from health professionals, regulatory agencies, and other customers regarding adverse experiences reported with Company products. This includes the authoring of Periodic Safety Update Reports (PSURs) and other regulatory documents.

**Key Responsibilities**

  • Leads signal detection, safety evaluation, and risk management planning for low-medium complex medicinal products and/or medical devices during clinical development and/or for established brands.
  • Leads pharmacovigilance and risk management planning and develops strategy for evaluation of issues in the clinical matrix.
  • Leads safety contributions to global regulatory submissions.
  • Ensures that appropriate safety objectives and risk minimization strategies are included in clinical development programs.

**Requirements**

  • 3-5 years of PV experience in the pharmaceutical industry.
  • Expert knowledge in pharmacovigilance and methodologies.
  • Sound knowledge of the therapeutic area of assigned products.
  • Experience in data analysis, signal detection, and benefit/risk evaluation.

**Education/Certificates**

  • MD-degree with clinical experience, ideally in Woman's Health or related fields.
  • MD/PhD/MSc Equivalent with experience in International Drug Safety.


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