PVQA Consultant

Contract/Interim PVQA Consultant needed for part time contract 60%. Ability to travel to Basel site advantageous.

BioTalent is partnered with and Swiss based BioTech company to find an experienced Consultant Pharmacovigilance Quality Assurance (PV QA) to drive compliance and quality assurance across a global Pharmacovigilance (PV) system. This role is critical in ensuring our marketing authorization holders and Qualified Persons for Pharmacovigilance (QPPV) meet international regulatory standards, supporting safe and effective patient outcomes worldwide.

Key Responsibilities:

• Expertise to lead PV compliance audit programs, managing audits across affiliates and ensuring a consistent, global quality system.
• Collaborate with internal and external stakeholders, delivering expert-level guidance on PV regulations and compliance.
• Oversee global and local quality system documentation, audit outcomes, and corrective actions.
• Act as local PV QA Manager for affiliate sites, guiding PV system implementation in line with company standards.
• Maintain inspection readiness and represent PV QA in regulatory inspections.
• Keep updated on PV regulations globally, advising on compliance impacts.

Ideal Candidate:

• 10+ years of QA/industry experience with a strong background in Pharmacovigilance.
• Proven audit and inspection experience; strong communication and collaboration skills.
• Involvement in set up of PV system (advantageous)
• Involvement in PV supplier selection, system improvement etc
• Expert knowledge GVP/GMP
• Master’s in Pharmacy or related field; expert in international PV regulations (EU, FDA, ICH).
• Fluent in English; knowledge of German/French advantageous.

If this role is for you please be in contact with dominic.pritchard@biotalent.ch +41415625046