Head of Country Pharmacovigilance (Local Safety Officer)
This role holds primary responsibility for all country pharmacovigilance (PV) core activities in Belgium & Luxembourg, and will provide managerial oversight for other markets in the cluster (Netherlands). This role acts as the point person with the Health Authority (HA) on safety related matters (Local PV nominated person).
The candidate will be responsible for:
• Leading and bringing to resolution with all appropriate functional groups, locally and globally, all product safety related issues that arise in the country.
• Acting as local subject matter expert (SME) for risk management (RM). Leading local implementation of Risk Minimization measures, in compliance with RMPs
• Acting as internal and external point of contact for the local HA for local interactions related to patient safety/ public health for the local market. Providing guidance on interpretation of local PV regulation.
• Ensuring audit and inspection readiness, facilitates and participates in PV related audits and inspections. Leading cross-functional teams to ensure that PV related audits/inspections are conducted effectively.
• Leading and managing all local PV staff and ensures that they are competent, trained and developed, effectively to perform their roles (2 direct reports).
• Ensures local implementation of Pharmacovigilance/Safety Data exchange Agreements
• Maintenance of PV Awareness and Training for non PV personnel
• Collecting, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases
• Ensuring timely and appropriate submission of single cases to local Health Agencies(HA) and Ethics Committees (as required)
• Planning, processing and reporting of Aggregate Reports to HA and EC (as required)