Our client, one of the world's largest biotech companies is looking for a Pharmacovigilance Officer to come on board to join their team in Belgium !
Main responsibilities :
- Implementation and maintenance of an effective local PV system for the respective affiliate(s)/country(ies) to ensure ongoing compliance with global and local legal / regulatory authority PV requirements.
- Support the oversight of the local PV system and this includes consistency in process execution, monitoring of the performance of the local PV system, proactive identification of actual or potential compliance gaps, and ensuring appropriate action is taken (including escalation to local and global senior management, as applicable) to prevent or resolve compliance issues.
- Development and implementation of the local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders and impact by the team of Patient Safety Partners to the Pharma Vision.
- ICSR (Individual Case Study Report) Oversight and Management
- Data collection
- Consumer Follow-up
- HCP Follow-up in local language
- Local Literature search, paper and online journals in local languages
- Pharmacovigilance System Master File (provide information and data relevant to the global PSMF
- Oversight of studies and local Compassionate Use Programs/Medical Need Programs (including review of protocols, safety data exchange agreements)
- Market research and patient support activities - approval, oversight & PV requirements set-up
- Oversight & Classification of Dicela projects (digital customer engagement & listening activities)
- Oversight of PV services providers including review of contracts and PV requirement set-up
- Risk Management and safety communication - local implementation
- Oversight and maintenance of the local PV system (including the activities performed by the Budapest PV Hub)
- Local QMS (local awareness, Procedural documentation, CAPA Management & tracking)
- Additional Monitoring Communication.
- Master's degree in Life Sciences.
- 2- 4 years' experience in Pharmacovigilance/Safety within the pharma industry.
- Fluent in English. Knowledge of Dutch or French is a strong asset as the person will be monitoring local mailboxes.
- Someone who can work independently, under minimal supervision.
- Balanced salary package based upon your experience and capabilities
- Full time position
- Hybrid model remote /office based
Vacancy number: 22151