Senior PV Lead

Vor 2 Tagen


Zug, Zug, Schweiz Randstad Switzerland Vollzeit

On behalf of our client, an international pharma company based in Switzerland, we are seeking a Senior PV Lead.

This role is fully remote from Switzerland.

You will serve as a global product lead for Pharmacovigilance activities within the Safety department including managing PV Scientists assigned to products.

General Information:

  • Contract type: temporary contract via Randstad
  • Duration: 1 year with the possibility of extension
  • Location: remote or office based in Baar if needed
Job Description

As a Senior PV Lead, you will lead the signal management process for assigned products and evaluate safety data and signals. You will also be responsible for synthesizing data from multiple sources and authoring signal evaluation reports.

Key Responsibilities:

  • Leads the signal management process for assigned products
  • Evaluates safety data and signals
  • Synthesizes data from multiple sources and authors signal evaluation reports
  • Provides strategic input to regulatory documents such as PSURs, DSURs, PADERs, and Addendum to Clinical Overview
  • Liaises with cross-functional project meetings and provides safety leadership

Your Profile:

  • MSc or BSc in biologic or natural science; or health care discipline advanced degree required
  • Minimum 7 years Pharmacovigilance experience, including experience in safety signal management and aggregate safety reports
  • Strong pharmacovigilance foundation, including knowledge of clinical trial safety regulations and post-marketing safety regulations
  • Ability to work with complex clinical data to produce robust assessments of safety data
  • Knowledge of common data processing software and safety database systems

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