Regulatory Affairs And Pharmacovigilance Officer H/F Vetoquinol

In this key position, you ensure the safety, compliance and integrity of Vetoquinol's products across BeNeSca. You act as the Regional Responsible Person for Pharmacovigilance and play an essential role in Regulatory Affairs, Deontology & Transparency, and Quality Assurance support.

Pharmacovigilance (PV)

- Act as the Local/Regional Responsible Person for Pharmacovigilance (LRRP).
- Manage and continuously improve the pharmacovigilance system in line with EU and national regulations.
- Collect, assess, and report adverse events within regulatory timelines, manage PV deviations and if necessary implement corrective and preventive actions.
- Prepare for and participate in authority inspections and internal PV audits.
- Deliver PV training to internal teams and third parties.
- Ensure PV agreements or clauses are in place with all relevant stakeholders.

Regulatory Affairs : Regulatory Compliance & Lifecycle Management

- Ensure compliance with national regulatory requirements.
- Manage the lifecycle of authorised veterinary medicinal products.
- Prepare, review and update product information, labelling and regulatory documents.
- Support new marketing authorisation applications and review promotional materials for regulatory compliance.
- Translate regulatory documents and package leaflets where required.

Deontology & Transparency

- Provide advice and approvals on gifts, sponsorships and benefits for veterinary healthcare professionals.
- Oversee accuracy of published product information on platforms such as pharma.be, FIDIN, Vetindex, company website.
- Prepare and submit annual transparency declarations.

Quality Assurance (Back-up Responsible Person)

In absence of the acting Responsible Person you will take on some of their responsibilities, such as: supporting recalls, handling customer complaints, CAPA management and documentation.