Job Description
My client a mid-sized pharma company based in Berkshire is seeking a Local Safety Officer (LSO) who will be responsible for managing pharmacovigilance (PV) activities ensuring compliance with local and global PV regulations.
1 day per week based in the office
Competitive salary, excellent benefits
1. Enter adverse event reports into safety databases (e.g. Argus / Global Intake Tool) under supervision
2. Manage the local safety mailbox and process spontaneous safety reports from healthcare professionals, patients, and other sources
3. Coordinate product quality complaints with the regional Quality team.Support signal detection activities and escalate local safety signals to global teams
4. Respond to safety-related requests from regulatory authorities and patient associations.
5. Conduct local literature screening for safety-relevant information not covered in global searches
6. Review and maintain local SOPs and contribute to global SOP reviews impacting PV.
7. Oversee aggregate reports (PSURs, DSURs), safety variations, and Risk Management Plans (RMPs)
8. Collaborate cross-functionally with medical, regulatory, quality, clinical, and commercial teams
9. Participate in audits, inspections, and ensure CAPAs are implemented effectively
10. Deliver basic PV training to new staff and external service providers
11. Ensure con...