Local Safety Officer
2 days ago
Windsor
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.