About the Company
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 Description
The 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
Requirements
- 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
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.