Local Contact Person – Pharmacovigilance, Regulatory Affairs

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

📋 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.

• Implement pharmacovigilance and regulatory affairs initiatives at the local level.

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

• Communicate efficiently and promptly with the MAH and local regulatory bodies.

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

• Offer local regulatory intelligence screening and expert advice for designated regions.

• Gather and report locally suspected ADRs or ICSRs, including necessary follow-ups and translations.

• Oversee risk minimization strategies related to urgent safety restrictions and emerging safety concerns.

• Assist in the development and implementation of the local pharmacovigilance system.

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

• Ensure the maintenance of accurate local records and documentation.

• Support the RA & PV Global Operations team.

• Prepare and compile documentation for submissions to regulatory authorities.

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

• Guarantee compliance with MAH and PrimeVigilance procedures.

• Assist with audits and inspections.

• Manage local QA responsibilities, including addressing suspected falsified products, health-authority quality alerts, and other local quality mandates.

⛳️ Requirements

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

• Minimum of 3 years of experience in pharmacovigilance or safety-related roles within a pharmaceutical, CRO, or regulatory setting.

• Solid understanding of ICH GVP and local pharmacovigilance requirements (through training or practical exposure).

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

• Prior experience in Regulatory Affairs is an asset but not essential.

• Proficient in English.

• Knowledge of additional languages (e.g., French) is a plus.

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

🏝️ Benefits

• Option for remote work.

• Collaborative and supportive team atmosphere.

• Flexible work culture.

• Opportunities for growth and professional development.

• Chance to collaborate with global teams and contribute to patient safety.

• A passionate team of experts in clinical research, pharmacovigilance, and quality consulting.