Pharmacovigilance Manager - Belgium, Netherlands
- The PV manager is responsible for the coordination and execution of all aspects of pharmacovigilance (drug safety) to ensure that all of company’s statutory and ethical responsibilities are met.
- The PV manager supports maintenance of the local pharmacovigilance system and pharmacovigilance reporting responsibilities under the supervision of the Head of Pharmacovigilance.
- Timely processing of Adverse event (AE)/SAEs (Serious Adverse Events)
- Reporting to local Health Authorities and Ethic Committees
- Compliance and Quality Control related activities
- Maintenance of Quality Documents/Local Operating Procedures
- Training activities
- Periodic Reporting
- Organized Data Collection (Patient Support Programs, Market Research)
Demands of the Position
- Min 2-3 years of experience in PV activities in the pharmaceutical industry
- Well established knowledge in PV legislation.
- Degree in life science-related discipline or professional equivalent.
- Strong preference for PV experience in relation to Patient Support Programs and Market Research
- Preferably, knowledge of working in a matrix environment
- Experience in working in a matrix environment