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We are thrilled to announce an exciting opportunity for a Pharmacovigilance Analyst to join our Belgium office, supporting pharmacovigilance activities within the France Benelux cluster.
Role Overview
As the Local Contact Person for Pharmacovigilance for Belgium, the Netherlands, and Luxembourg, you will collaborate closely with the Global Patient Safety team to maintain an efficient local Pharmacovigilance (PV) system. This system must align with European and national regulations, as well as Baxter procedures. This role presents an outstanding opportunity to contribute to a world-class team and make a significant impact on patient safety.
What you'll do :
1. Management of Local PV Cases: Collect, document, and follow up on PV cases in accordance with established procedures to ensure efficient management and regulatory compliance.
2. PV Quality Activities: Conduct reconciliations, quality control (QC), and deviation management/CAPA processes, supervise critical metrics, and participate in quality reviews to ensure the PV system's efficiency and maintain outstanding standards.
3. Preparation and Participation in Audits/Inspections: Prepare for and participate in internal and external audits/inspections, ensuring all documentation and processes are audit-ready and aligned with regulatory standards, and collaborate with cross-functional teams to address findings and implement corrective actions.
4. Participation in the implementation of SDEA/PV Agreements: Support the establishment, maintenance, and seamless integration of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance (PV) Agreements, ensuring compliance with regulatory standards.
5. Support of France PV Team: Assist the France PV team with daily tasks and projects to ensure smooth operations and collaborative compliance throughout the France Benelux Cluster, fostering collaboration and knowledge sharing for flawless execution of PV activities.
What you'll bring :
6. Degree or equivalent experience in Medicine or Pharmacy, or a Master's degree or equivalent experience in Sciences (biology) to provide a strong foundation in healthcare and scientific principles.
7. Outstanding communication skills in English, Dutch, and French to ensure effective documentation and teamwork in a multilingual environment.
8. Proven ability to manage PV cases strictly in compliance with regulatory requirements.
9. Strong analytical skills for monitoring critical metrics and implementing effective quality control measures.
10. Additional certifications or training in Pharmacovigilance or related fields are advantageous.