Local Contact Person – Pharmacovigilance and Regulatory Affairs

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

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

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

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

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

• Communicate promptly and effectively with the MAH and local regulatory agencies.

• Act as the primary liaison with local regulatory bodies regarding Regulatory Affairs and Pharmacovigilance.

• Provide local regulatory intelligence screening and expert guidance for designated regions.

• Collect and report locally suspected ADRs or ICSRs, including follow-up actions and translations.

• Manage or oversee risk mitigation measures associated with urgent safety restrictions and emerging safety concerns.

• Support the development and implementation of the local pharmacovigilance system.

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

• Maintain precise local records and documentation.

• Assist the RA & PV Global Operations team.

• Prepare and gather documentation for submissions to regulatory authorities.

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

• Ensure compliance with MAH and PrimeVigilance protocols.

• Support audits and inspections.

• Manage local QA responsibilities, including suspected counterfeit products, quality alerts, and other local market quality requirements.

⛳️ 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 context.

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

• Experience in case handling, literature screening, or local PV activities is desirable.

• Previous experience in Regulatory Affairs is preferred, but not essential.

• Proficient in English.

• Knowledge of additional languages is advantageous.

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

🏝️ Benefits

• Flexible work arrangements / remote work options.

• Collaborative and supportive team environment.

• Opportunities for growth and professional development.

• Exposure to a global team and international work settings.