Pharmacovigilance QA Manager

​Pharmacovigilance Quality Assurance (PV QA) Manager

Location: Allschwil, Switzerland
Schedule: Full-time (100%)
Start Date: ASAP
Duration: 12 months

Are you ready to lead the charge in safeguarding patient safety and ensuring compliance in the pharmaceutical industry? Join the team as the Pharmacovigilance Quality Assurance (PV QA) Manager in Allschwil, Switzerland, where you'll play a pivotal role in maintaining and enhancing a global PV system. This is more than just a job—it's an opportunity to make a tangible impact on public health.

Key Responsibilities:

As the PV QA Manager, you'll be the driving force behind the planning, execution, and continuous improvement of PV compliance audit programs. Your expertise will ensure that the global PV system aligns with international regulations, safeguarding the integrity of operations across the affiliate sites.

• Leadership & Strategy: Serve as the primary contact for internal stakeholders, providing expert-level guidance on complex pharmacovigilance issues. Lead key projects and drive policy decisions that enhance our compliance framework.

• Audit Excellence: Independently manage a risk-based global PV QA audit program, conducting audits of vendors and affiliates, and ensuring audit results are meticulously tracked, reported, and acted upon.

• Regulatory Compliance: Collaborate with EU QPPV and national Affiliate Safety Managers, ensuring inspection readiness and interacting with Competent Authorities during inspections.

• Quality System Oversight: Maintain and improve our quality system, ensuring CAPA effectiveness, training compliance, and alignment with global and local quality standards.

• Continuous Learning: Stay ahead of global pharmacovigilance regulations, evaluate changes in country-specific laws, and ensure our practices reflect the latest standards.

What We're Looking For:

We need a dynamic individual with a strong background in Pharmacovigilance/Drug Safety, Quality Assurance, and Auditing. You should have:

• Expertise: 10+ years in QA, with deep knowledge of international pharmacovigilance regulations (EU, US, Health Canada) and experience conducting PV audits.

• Regulatory Experience: Proven track record in coordinating pharmacovigilance inspections by major health authorities (e.g., FDA, EMA).

• Communication: Exceptional verbal and written communication skills, with the ability to foster collaborative relationships and navigate complex regulatory environments.

• Languages: Fluent in English, with German and French as advantageous assets.

Apply Now and be part of a team that is committed to excellence in pharmacovigilance and patient safety.

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