Local Contact Person – Pharmacovigilance, Regulatory Affairs

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

📋 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.

• Carry out local pharmacovigilance and regulatory affairs tasks.

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

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

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

• Evaluate local regulatory intelligence and offer expert counsel.

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

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

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

• Conduct local non-indexed literature screening and review regulatory authority websites for 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 adherence to MAH 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 equivalent professional experience.

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

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

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

• Previous experience in Regulatory Affairs is advantageous but not essential.

• Proficient in English.

• Knowledge of additional languages is a plus.

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

🏝️ Benefits

• Option for remote work.

• Collaborative team culture.

• Opportunities for professional growth.

• A diverse and inclusive work environment.

• Chance to engage in projects with a global impact.

• Dedicated team of specialists in clinical research, pharmacovigilance, and quality consulting.