My client a global bio-pharmaceutical company focused on developing and commercializing innovative medicines they are looking for a Pharmacovigilance Officer to join their team near Brussels.
The company is searching for a Pharmacovigilance Officer to support the pharmacovigilance operations currently limited to safety in clinical development, later to be extended to post-authorisation pharmacovigilance.
The candidate (m/f) will report to the Head of Pharmacovigilance Operations.
- Evaluation and QC review of draft SAE reports.
- Monitoring compliance of regulatory reports: SUSAR, ASRs and 6-monthly line listing including distribution lists and timelines.
- Active management of pharmacovigilance service provider
- Prepare, review and/or contribute to PV and safety containing documents (protocols, FSR, IBs, periodic safety reports, DDPS, RMPs, CCSI, etc.)
- Maintain the service provider updated on the relevant documents needed to perform the contracted activities (IBs, protocols, lists of participating centres, etc.)
- Assistance with SAE reconciliation.
- Act as main contact liaison between the PV service provider, the CRO, TG project managers, medical and other functions as necessary.
- Maintenance of TG Safety archive, which include: vendor contracts, project safety plan, SAE forms and instructions, Regulatory documentation: ASR, 6-Month line listings, SUSARs, Regulatory requirements, SAE listings for each project, ARGUS Documentation and Eudravigilance documentation
- Prepare and review SOPs.
- Other PV related activities as requested by line manager.
- You have a degree in a biological science with at least 4 years (bio)pharmaceutical experience in pre- and post-authorisation pharmacovigilance including writing of PV reports(PSURs,DSURs) knowledge of pharmacovigilance regulations and guidelines.
- You are familiar with Quality aspects related to PV.
- You are fluent in English, both verbal and written (capable of writing clearly and accurately). Knowledge of other languages will be a plus.
- You show initiative, proactiveness and a quality-driven approach to work, and team spirit.
- You have good interpersonal, communication and organization skills.
- You are PC literate; knowledge of any PV software system (ARGUS, ARISg) would be an advantage.
Please contact Emma Hobbs on +44 1483 397070 firstname.lastname@example.org to discuss this position in more detail.