Local Contact Person – Pharmacovigilance and Regulatory Affairs

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Serve as the Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA).

• Act as the main local representative for RA&PV to ensure adherence to national pharmacovigilance and regulatory standards in Australia.

• Carry out local pharmacovigilance and regulatory affairs initiatives.

• Assist the Marketing Authorisation Holder in upholding product compliance throughout its lifecycle.

• Communicate swiftly and effectively with the MAH and local regulatory bodies.

• Act as the primary liaison with local regulatory authorities concerning Regulatory Affairs and Pharmacovigilance.

• Provide local regulatory intelligence assessments and expert guidance.

• Gather and report locally suspected ADRs or ICSRs, along with follow-ups and translations.

• Manage or supervise risk minimization strategies related to urgent safety restrictions and emerging safety concerns.

• Aid in the development and execution of the local pharmacovigilance system.

• Conduct local non-indexed literature reviews and regulatory authority website screenings for potential ADRs and safety information.

• Ensure the maintenance of precise local records and documentation.

• Support the RA & PV Global Operations team.

• Prepare and assemble documents for regulatory authority submissions.

• Review and provide linguistic feedback on local Product Information and mock-ups.

• Ensure adherence to MAH and PrimeVigilance protocols.

• Assist with audits and inspections.

• Manage local QA responsibilities, including issues related to suspected falsified products, health-authority quality alerts, and other local market quality needs.

⛳️ Requirements

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience.

• Minimum of 3 years of pharmacovigilance or safety-related experience in the pharmaceutical, CRO, or regulatory field.

• Solid understanding of ICH GVP and local pharmacovigilance regulations (either through training or practical experience).

• Preferred experience in case handling, literature screening, or local PV activities.

• Previous experience in Regulatory Affairs is advantageous but not essential.

• Proficiency in English is required.

• Additional language skills are a plus.

• Strong proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.

🏝️ Benefits

• Option for remote work.

• Collaborative team atmosphere.

• Flexible work culture.

• Opportunities for growth.

• An inclusive and welcoming workplace culture.

• Chance to collaborate with global experts in clinical research, pharmacovigilance, and quality consulting.