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Senior Drug Safety Scientist

Senior Drug Safety Scientist

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Senior Drug Safety Scientist

  • Location:

    Basel

  • Sector:

    Pharmavigilence

  • Contact:

    Edward Jessel

  • Salary:

    Negotiable

  • Job type:

    Permanent - full time

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/03539_1601284190

  • Published:

    21 days ago

  • Startdate:

    ASAP

Global Senior Safety Scientist

MSI Pharma is currently working with Growing Biotech to help them hire a permanent Senior Safety Scientist to join their team in Basel. The team is currently small, so the new hire will have the chance to get involved with a wide range of safety activities with the end goal being a successful regulatory submission.

Main Focus:

To support the department head with scientific analyses, data reviews, signal management and risk assessment activities, evaluation of product quality issues and emerging safety issues, including contribution to safety documents

  • Ensure high quality, accurate scientific contributions to the safety evaluation of products both during development and after marketing authorisation approval
  • Contribute to the preparation and review of pharmacovigilance documentation for internal and external use
  • Ensure the timely provision of all safety deliverables to enable progress with clinical trials (interventional and non-interventional), including facilitating the activities of Data Safety Monitoring Committees
  • Overall contribution to Global Patient Safety vision and compliance

Experience & Qualifications:

  • Bioscience graduate (BSc, PharmD)
  • Fluent in written and spoken English
  • Awareness of pre- and post-marketing PV legislation
  • Proven scientific analytical skills
  • Previous experience of pharmacovigilance, either in industry or in a health authority
  • Knowledge of product development processes and experience of cross-functional team work
  • Sound knowledge of pharmacovigilance legislation
  • Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission files
  • Experience with Aggregate reports, and safety sections of regulatory documents

Key words:

Pharmacovigilance, Permanent, Safety Data, PV, Drug Safety, Global Safety, Risk Management,