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
* Enter adverse event reports into safety databases (e.g. Argus / Global Intake Tool) under supervision
* Manage the local safety mailbox and process spontaneous safety reports from healthcare professionals, patients, and other sources
* Coordinate product quality complaints with the regional Quality team.Support signal detection activities and escalate local safety signals to global teams
* Respond to safety-related requests from regulatory authorities and patient associations.
* Conduct local literature screening for safety-relevant information not covered in global searches
* Review and maintain local SOPs and contribute to global SOP reviews impacting PV.
* Oversee aggregate reports (PSURs, DSURs), safety variations, and Risk Management Plans (RMPs)
* Collaborate cross-functionally with medical, regulatory, quality, clinical, and commercial teams
* Participate in audits, inspections, and ensure CAPAs are implemented effectively
* Deliver basic PV training to new staff and external service providers
* Ensure continuity of local PV activities, including out-of-hours coverage and business continuity planning.
Qualifications & Skills
* Graduate science degree in health / life sciences
* Minimum of 3 years PV experience
* Good knowledge of Pharmacovigilance legislation where appropriate.
* Practical experience in process development and improvement activities that embed quality and drive continuous improvement.
* Experience in process mapping and writing process documents.
* Flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, facilitates and drives change where appropriate.
* Challenges and questions ways of working to seek improved processes.
* Excellent attention to detail.
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