Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & German

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting 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 as per local requirements
• 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 such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market