Full-Time Local Contact Person for Pharmacovigilance & Regulatory Affairs

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative for ensuring compliance with national pharmacovigilance and regulatory requirements.

This dual-role position supports the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.

Main Responsibilities:

• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance.
• Prompt and effective communication with local regulatory authorities.
• Provision of local regulatory intelligence screening and expert advice.
• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations).
• Local management/oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues.
• Preparation and collection of documentation for submissions to the regulatory authorities.
• Review and linguistic input on local Product Information and Mock-ups.
• Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations.
• Perform local non-indexed literature screening and screening of regulatory authority website(s) for potential Adverse Drug Reactions (ADRs) and safety information.
• Maintain accurate records and documentation at local level.
• Provide support to the RA & PV Global operations team.
• Ensure compliance with MAH's and PrimeVigilance's procedures.
• Support audits and Inspections.
• Handle local QA tasks (suspected falsified products, quality alerts, quality-related requirements from the local market).

Qualifications:

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience.
• Minimum 3 years within pharmaceutical or CRO industry or regulatory authority.
• Minimum 2 years within LCPPV role, or relevant pharmacovigilance experience in safety-related position.
• Pharmacovigilance training and/or working experience and other educational or professional background as required by local regulations.
• Prior experience in Regulatory Affairs is preferred but not mandatory.
• Expert knowledge of ICH GVP and relevant local legislation/regulatory requirements.
• Proficiency in English and French, both written and verbal.
• Strong skills in Microsoft Office applications (Word, Excel, PowerPoint).

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