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Drug Safety Physician

Drug Safety Physician

  • Location

    Maidenhead, Berkshire

  • Sector:

    Pharmacovigilance

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Joe Haskell

  • Contact email:

    info@pharma-partners.co.uk

  • Job ref:

    12345_1654002769

  • Published:

    about 1 month ago

  • Expiry date:

    2022-06-30

  • Consultant:

    #

Drug Safety Physician

I am currently working with a leading, global vaccine company looking to hire an experienced drug safety/pharmacovigilance physician. This role is responsible for the medical expertise on all aspects of safety throughout the entire lifecycle of the assigned products. This individual will apply sound medical judgment for the analysis and interpretation of complex data for signal detection, substantiation and initiation of safety risk management activities including and not limited to risk minimization activities and evaluation of the effectiveness of risk mitigation measures. The role integrates these safety risk management activities of a given product, into the regulatory and business context.

Responsibilities:

  • Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of single and/or aggregate safety data and literature during all phases of the life cycle of a defined portfolio of medicinal products.
  • Lead the cross-functional Safety Management Teams regarding safety relevant topics and escalate all safety relevant matters to the appropriate decision making level with proposals for solutions based on analysis of the available information.
  • Accountable for the appropriateness of the content of safety documents such as RMPs, PSURs, DSURs, and safety sections of CSRs, labelling documents.
  • Interface with other departments (e.g. clinical development, regulatory and medical affairs, manufacturing and epidemiology) with regard to safety aspects of the given portfolio. In cross-functional setting, the BRMP is responsible and accountable for the following in the given products.

Requirements:

  • Qualified Physician with previous clinical experience
  • Previous experience in Benefit-Risk Management and Clinical Trial Safety is required
  • Exposure to Clinical Development and/or clinical safety of at least 1 product submitted to Regulatory Authorities for marketing authorization.
  • Excellent communication skills, including formal presentation skills.

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer