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 Regulatory Affairs & Pharmacovigilance (RA&PV).

• Ensure adherence to national pharmacovigilance and regulatory standards in Australia.

• Implement local pharmacovigilance and regulatory affairs initiatives.

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

• Communicate efficiently and effectively with the Marketing Authorisation Holder and local regulatory bodies.

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

• Analyze local regulatory intelligence and offer expert guidance.

• Gather and report locally suspected Adverse Drug Reactions (ADRs) or Individual Case Safety Reports (ICSRs), including follow-ups and translations.

• Manage or supervise risk minimization strategies associated with urgent safety restrictions and emerging safety concerns.

• Assist 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.

• Maintain precise local records and documentation.

• Support 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 Marketing Authorisation Holder and PrimeVigilance procedures.

• Assist with audits and inspections.

• Manage local quality assurance responsibilities, including suspected counterfeit products and health authority quality alerts.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Chemistry, Nursing, or a related professional background.

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

• Strong understanding of ICH Good Pharmacovigilance Practices (GVP) and local pharmacovigilance regulations.

• Proficient in English.

• Knowledge of additional languages is a plus.

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

• Previous experience in Regulatory Affairs is beneficial but not required.

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

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for growth and professional development.

• A collaborative and supportive work atmosphere.

• Global team environment.

• Chance to contribute to patient safety and pharmaceutical advancements.

• A passionate and collaborative team of professionals.

• A workplace focused on belonging, where every voice is valued.