An innovative international biopharmaceutical organization is looking to strengthen its Global Drug Safety & Pharmacovigilance (GDS&PV) Compliance team. Operating in a highly regulated environment, the company is committed to maintaining the highest standards of inspection readiness, regulatory compliance, and patient safety across its global operations.
Role DescriptionThe role supports the GDS&PV Compliance function in ensuring inspection readiness, audit coordination, document governance, and pharmacovigilance (PV) process support. You will play a key operational role in preparing for audits and health authority inspections, maintaining compliance documentation, and supporting PV process owners with structured follow-up and oversight activities. This position requires strong organizational skills, regulatory awareness, and the ability to manage multiple stakeholders in a fast-paced, compliance-driven environment.
Key Responsibilities- Coordinate and support preparation activities for internal audits, partner audits, and health authority inspections
- Maintain audit and inspection trackers, action plans, timelines, and documentation repositories
- Organize meetings, interviews, and readiness activities related to audits and inspections
- Coordinate collection, organization, and version control of requested documentation
- Track audit and inspection findings, follow up on actions and commitments with compliance and process owners
- Support inspection readiness initiatives, including evidence repositories and structured oversight tools
- Support maintenance of selected SOPs, Work Instructions (WIs), and templates under Compliance ownership
- Coordinate document updates, reviews, approvals, and version control within the document management system
- Bachelor’s degree or equivalent with 6+ years of relevant industry experience within pharmacovigilance or regulated drug development environments
- Strong knowledge of regulatory guidelines and policies related to drug safety and pharmacovigilance
- Experience supporting audits, inspections, compliance activities, or document governance processes
- Proactive, structured, and goal-oriented working style
- Strong collaboration skills, with the ability to work cross-functionally with stakeholders such as Scientists, Clinical Teams, Medical Affairs, Commercial, and QA
- Excellent written and verbal communication skills
€55000 - €75000 monthly