Contractor Local Contact Person for Pharmacovigilance

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative for compliance with national pharmacovigilance and regulatory requirements. This dual-role position supports the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.

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

• Bachelor's Degree in Life Sciences or 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 in territories of competency.
• Proficiency in English & French, both written and verbal.
• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

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