Local Contact Person – Pharmacovigilance, Regulatory Affairs

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

📋 Description

• Timely and effective communication with the Marketing Authorization Holder (MAH) and local regulatory authorities as necessary.

• Serve as the primary liaison with local regulatory bodies concerning Regulatory Affairs and Pharmacovigilance according to local standards.

• Provide local regulatory intelligence analysis and expert guidance for the designated region(s).

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

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

• Assist in the development and implementation of the local pharmacovigilance system, ensuring compliance with the Global MAH's system and local regulations.

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

• Maintain precise records and documentation at the local level.

• Provide assistance to the RA & PV Global operations team.

• Prepare and collect documentation for submissions to regulatory authorities.

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

• Ensure adherence to the procedures of the MAH and PrimeVigilance.

• Support audits and inspections.

• Manage local Quality Assurance tasks such as investigating suspected counterfeit products, addressing quality alerts from health authorities, and fulfilling other quality-related requirements from the local market.

⛳️ Requirements

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

• 2-4 years of experience in pharmacovigilance or safety-related roles within pharmaceutical, CRO, or regulatory settings.

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

• Preferred experience in case handling, literature reviews, or local pharmacovigilance activities.

• Prior experience in Regulatory Affairs is advantageous but not required.

• Proficiency in English, with knowledge of an additional language (e.g., French) being a plus.

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

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional growth.

• A friendly and supportive workplace environment.

• The chance to collaborate with colleagues around the globe, with English as the primary language of communication.