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Senior Safety Scientist - Remote EU

Senior Safety Scientist - Remote EU

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Senior Safety Scientist - Remote EU

  • Location:

    Belgium

  • Sector:

    Pharmacovigilance

  • Contact:

    Edward Jessel

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/03669_1613991534

  • Published:

    9 days ago

  • Duration:

    6 months

  • Startdate:

    ASAP

Safety (PV) Writing Scientist - Freelance - EU


MSI Pharma is working with a global biopharma to source a Safety Writing Scientist to support the Global Patient Safety group for an initial 6 month freelance contract.


The client are based in the Belgium and will offer remote working anywhere in the EU

The role;

  • As the Safety Writing Scientist, you will be writing benefit-risk assessments, safety risk management strategies, safety signal assessments, regulatory submissions, aggregate reports, and publications.
  • You will lead the preparation of Patient Safety deliverables, including planning, contributing to analysis strategy, writing, presentation as well as review and approval of documents and deliverables in scope: DSUR, SMR, PBRER /PSUR, SSAR, SOV, RMP, PAER, SRM Strategy document, regulatory responses, submission documents, relevant and other regulatory and safety annual reports.
  • You will provide mentorship to relevant vendors and oversee the work, ensuring the final deliverables meet quality guidelines.
  • Perform literature review and summary of literature for AR, RMP, epidemiology, product renewals, safety evaluations
  • Assure quality and consistency across Patient Safety deliverables, including compliance with regulatory requirements and compliant with agreed and defined timelines
  • Present analysed relevant adverse event/scientific/clinical/epidemiological data to a variety of audiences
  • Collaborate in the planning, preparation, and review of epidemiologic/scientific manuscripts, abstracts, posters, etc for submission to scientific journals/conferences including generation of lay language summaries for patients as necessary

You should have:

  • Bachelor's Science degree or the equivalent is an absolute must
  • As is extensive experience in pharmacovigilance, medical writing, including working with vendors, clinical safety or clinical development
  • A good understanding of applicable regulations in pharmacovigilance and clinical development
  • Have the ability to project manage deliverables in a matrix environment with competing priorities