Senior Physician Safety Writer H/F

il y a 2 semaines


Guyancourt, Île-de-France Baxter Temps plein

Vantive: A New Era in Kidney Care

Baxter is embarking on a transformative journey to separate its ~$5B Kidney Care segment into a standalone company, Vantive. This new entity will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis, providing best-in-class care to those we serve.

At Vantive, you will become part of a community of individuals driven to improve patients' lives worldwide. Our team is focused, courageous, and committed to excellence. We are seeking a Senior Physician Safety Writer (PSW) to join our ranks.

Key Responsibilities

  • Prepare, review, and distribute aggregate safety reports (ASRs) and pharmacovigilance risk management plans (PV-RMPs) for submission to regulatory agencies worldwide.
  • Ensure compliance with regional and local regulatory requirements.
  • Perform quality control reviews of ASRs and PV-RMPs.
  • Facilitate cross-functional document review and approval.
  • Manage project timelines and deliverables.

Requirements

  • Medical degree with a minimum of 2 years pharmacovigilance industry experience.
  • Prior experience authoring ASRs/PV-RMPs and providing medical knowledge for safety signal work-ups and benefit-risk assessments is desired.
  • Excellent scientific/clinical writing and editorial skills.
  • Outstanding verbal and written communication skills in English.
  • Highly proficient computer skills and familiar with electronic publishing.

What You'll Bring

  • Medical expertise and knowledge of pharmacovigilance regulation requirements.
  • Ability to perform detailed scientific analysis/evaluation of specialized information.
  • Strong analytical and problem-solving skills.
  • Ability to work effectively in a global team environment.

About Vantive

Vantive is a new company built on our legacy in kidney care. We are committed to providing best-in-class care to those we serve. Our team is driven to improve patients' lives worldwide.


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