Associate Drug Safety Manager (UK, Ireland, Nordics)

• Drug Safety operations for the local pharmacovigilance system and Deputy Local Responsible Person for Pharmacovigilance (LRP-PV) for United Kingdom, Ireland and Nordics (UKINOR) with the Local Drug Safety department.
• Work with and deputize for the LRP-PV to maintain a local pharmacovigilance system to perform tasks to comply with national pharmacovigilance requirements and company standards to ensure products maintain favorable benefit safety profile.
• Assist the LRP-PV in supporting the local commercial business, Drug Safety business continuity, and back up processes.
• Active in maintaining the local pharmacovigilance system including tasks such as procedural updates, training personnel, deviation and CAPA management, audit/inspection support and monitoring for changes in local pharmacovigilance regulations.
• Assist in drug safety agreement and service provider management.
• Monitor, collect and follow-up of safety information (signals, spontaneous and solicited cases) from different sources/channels (e.g. digital/social media, organized data collection programmes, local literature); manage and report safety cases internally through existing systems and procedures.
• Assist in management of pharmacovigilance requests (e.g. questions, local data required for safety report generation), audits and inspections.
• Support the implementation and monitoring of safety measures locally for patient safety (e.g. implementation of additional risk minimization measures).
• Quality control checks, filing, tracking, and archiving of the local pharmacovigilance related documentation (e.g. safety cases, safety data outputs).
• Collaborate within Global Drug Safety in Drug Safety international tasks/projects across territories to support pharmacovigilance activities.

• Language skills: Business English; Nordic language skills beneficial.
• Microsoft based and general IT competence.
• Proactive and solution orientated to contribute to a high performing pharmacovigilance system and being patient-centric..
• Ability to work within an international matrix Drug Safety environment
• Passion for pharmacovigilance.
• Relevant experience/understanding of the pharmaceutical industry, with a strong focus on pharmacovigilance operations within a local affiliate.
• Scientific /(para)medical degree (e.g. pharmacist, biological sciences).
• Ability to attend the Maidenhead office as required