Local Contact Person, Pharmacovigilance, Regulatory Affairs

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

📋 Description

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

• Function as the primary local RA & PV representative to ensure 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 maintaining product compliance throughout its lifecycle.

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

• Act as the main liaison with local regulatory authorities for Regulatory Affairs and Pharmacovigilance.

• Evaluate local regulatory intelligence and provide expert advice for the respective regions.

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

• Manage or oversee risk minimization strategies concerning 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 monitor regulatory authority websites for potential ADRs and safety information.

• Maintain precise local records and documentation.

• Support the RA & PV Global Operations team.

• Prepare and compile documentation for regulatory authority submissions.

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

• Ensure compliance with MAH and PrimeVigilance protocols.

• Assist with audits and inspections.

• Undertake local QA responsibilities, including suspected falsified products, quality alerts, and other local quality obligations.

⛳️ Requirements

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

• A minimum of 3 years of pharmacovigilance or safety-related experience in a pharmaceutical, CRO, or regulatory setting.

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

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

• Previous experience in Regulatory Affairs is an advantage but not essential.

• Proficient in English.

• Knowledge of additional languages is beneficial.

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

🏝️ Benefits

• Option for remote work.

• Flexible work environment.

• Opportunities for growth and professional development.

• Collaborative and supportive team culture.

• Inclusive workplace fostering belonging.

• Chance to engage in globally impactful patient-safety activities.

• Options for permanent or contractor engagement.