Safety Officer
Join Excelya, where Audacity, Care, and Energy define who we are and how we work.
We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth
Mains Responsibilities :
The position involves performing as Local Contact Person responsible for Pharmacovigilance for Belgium and the Netherlands and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.
Work in several aspects of pharmacovigilance shall be expected, such as
· Performs local literature search/review or quality control on results, maintain local journal/conference lists
· handles case reports, complaints, queries (from collection to reporting to Client/Authorities)
· Prepares/reviews aggregate reports (e.g. PSURs/PBRERs)
· Prepares Risk Management Plans
· Assists in handling/monitoring additional risk minimisation activities
· Maintenance of the PV System
· Participate in/conduct trainings
· Participate in audits/inspections