Pharmacovigilance QA Manager

vor 17 Stunden

Basel, Basel-Stadt, Schweiz Hydrogen Group Vollzeit CHF 95'000 - CHF 140'000 pro Jahr

Overview

We are searching for an experienced QA leader to oversee global Pharmacovigilance quality activities. You will drive the PV audit strategy, strengthen affiliate PV systems, ensure inspection readiness, and work closely with the EU QPPV and local safety teams.

Responsibilities

  • Lead the global PV audit program for internal processes, partners, and vendors.
  • Ensure affiliates consistently apply corporate PV standards and procedures.
  • Maintain a risk-based audit plan and coordinate external QA support.
  • Monitor audit outcomes, follow-up actions, and quality improvements.
  • Act as QA representative during health authority inspections.
  • Contribute to the PSMF and ensure documentation and training oversight.
  • Support affiliates with deviations, CAPAs, and quality events.
  • Track global PV regulatory changes and assess system impact.
  • Promote a strong quality and compliance culture.

Requirements

  • Advanced degree in Pharmacy or life sciences.
  • Solid PV/Drug Safety and QA background with strong understanding of global PV regulations.
  • 10+ years of relevant experience, including leading PV audits.
  • Proven track record supporting major regulatory inspections.
  • Strong problem-solving, risk-based thinking, and communication skills.
  • Fluent in English; German or French beneficial.
  • Experience in GDP, distribution, and affiliate QA is a plus.

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