Senior Pharmacovigilance Specialist – Belgium and Luxembourg M/F/D

Job Description

Do you have a degree in health, life science, medical science, regulatory affairs or equivalent by experience and at least two years of industry experience in pharmacovigilance? If you answered yes, we have a role for you!

For our Pharmacovigilance Department in Brussels we are currently recruiting a:

Senior Pharmacovigilance Specialist – Belgium and Luxembourg M/F/D

The position

As a Senior Pharmacovigilance Specialist, you will be contributing to the day-to-day activities of the Pharmacovigilance (PV) Department in Brussels covering Belgium and Luxembourg. You will be responsible for PV activities (as delegated or assigned by your manager) which may include but are not limited to: PV intake, management and negotiation of local PV agreements, local due diligence activities, implementation and oversight of risk minimization measures, participation in audits and inspections and related readiness activities.

Activities would include, e.g.:

• Developing local procedures (in compliance with regional and standards) for the department to ensure quality PV data and processes.
• Responsible for day-to-day adverse events case management.
• Interfacing with colleagues from different functional areas, e.g. local Clinical Trial Operations, Regulatory Affairs department, to ensure alignment on issues impacting PV.
• Supporting local initiatives (e.g. digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable. Serving as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
• You will report into the Director PV Cluster Lead BeNeLux / PV Lead BeLux.

Position Qualifications:

• Master’s/ bachelor’s degree in health, life science, medical science, regulatory affairs or equivalent by experience.
• At least two years of industry experience in pharmacovigilance or regulatory affairs in a pharmaceutical company/health authorities’ organization/ CRO/ consulting company providing pharmacovigilance services.
• Knowledge of pharmacovigilance regulations in Belgium and Luxembourg and experience in interacting with PV auditors and preferably PV inspectors.
• Fluency in at least 1 local language – French or Dutch; Dutch being a strong preference, and some working knowledge of the second language highly desirable.
• Ability to work in partnership with others (internally and externally) to accomplish quality goals.
• Problem solving skills using creative thinking and data-collection from appropriate stakeholders to respond to new, complex, or problematic situations to influence organization direction.