Are you an experienced Pharmacovigilance Manager looking to join one of the leading service companies for the Pharmaceutical Industry globally specialising in all aspects of drugs and medical devices approval.
My client is looking to hire an experienced Pharmacovigilance Manager to join their UK hub based in Buckinghamshire. You will be responsible for leading the Pharmacovigilence aspects of the project for the pre-approval and post-approval phase/s.
Your responsibilities will include:
- Provide assistance to Qualified Person(s) for Pharmacovigilance (QPPV) and act as Deputy QPPV
- Evaluation of the benefit-risk profile of drugs based on current scientific knowledge – this includes the creation of safety update reports PSURs (Periodic Safety Update Reports) and associated documents such as AdCOs (Addendum to the Clinical Overview), DSURs (Development Safety Update Reports), RMPs (Risk Management Plans) and signal detection reports
- Creation and assessment of Individual Case Safety Reports (ICSRs) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; decision on expedited reporting; reporting of ICSRs to the competent authorities
- Communication with regulatory authorities and client companies with regard to all pharmacovigilance-focused aspects
- Writing/Review of QA documents such as Working Instructions, SOPs, Working Procedures, Templates, Project Metafiles etc. for PharmaLex pharmacovigilance projects
- Complete and submit XEVPRMs on behalf of clients
- Receive and handle medical information enquiries according to project processes
- Identification and appropriate processing of safety information received within medical information enquiries
- Knowledge in the field of pharmacology and medicine
- Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
The role is offering a competitive salary plus an excellent benefits package alongside the opportunity to work for a truly progressive company who can offer an experienced PV Manager a platform for fast tracked career progression.