Full-Time Local Contact Person Pharmacovigilance

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

Dual-role position executing PV and RA activities locally, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance.

Main Responsibilities:

• Primary contact 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 Adverse Drug Reactions (ADRs) or ICSRs (FUs, translations).
• Local management/oversight of risk minimization measures related to safety restrictions and emerging safety issues.
• Preparation and collection of documentation for regulatory submissions.
• Review and linguistic input on local Product Information and Mock-ups.
• Development and implementation of local pharmacovigilance system complying with Global MAH's system and local regulations.
• Local non-indexed literature screening and regulatory authority website screening for potential ADRs and safety information.
• Accurate records and documentation at local level.
• Support to the RA & PV Global operations team.
• Compliance with MAH's and PrimeVigilance's procedures.
• Support audits and inspections.
• Local QA tasks (suspected falsified products, quality alerts, other quality 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.
• Pharmacovigilance training and/or working experience.
• Prior experience in Regulatory Affairs preferred.
• Expert knowledge of ICH GVP and relevant local legislation/regulatory requirements.
• Proficiency in English and French (written and verbal).
• Strong Microsoft Office skills (Word, Excel, PowerPoint).

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