Associate Drug Safety Manager (UK, Ireland, Nordics)
If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development - Drug Safety, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the life of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.
What the job looks like
Each day you will enjoy a variety of challenges such as:
- 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.
What you’ll bring to the table
To make the most of this role and truly thrive, you should have:
- 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
______________________________________