Local Contact Person for Pharmacovigilance and Regulatory Affairs

Summary

Join PrimeVigilance, a global leader in pharmacovigilance, as the Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA). This dual-role position ensures compliance with national requirements, acting as the primary local representative for regulatory authorities. You will execute PV and RA activities, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance. Key responsibilities include communication with regulatory authorities, providing regulatory intelligence, collecting and reporting adverse drug reactions, managing risk minimization measures, preparing documentation for submissions, and ensuring compliance with procedures. PrimeVigilance offers excellent training, development, and a supportive work environment. This role requires a Bachelor's degree in Life Sciences or equivalent, minimum 3 years in pharma or CRO, and 2 years in an LCPPV role or similar.

Requirements

• 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
• Expert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competency
• Proficiency in English and Polish, both written and verbal
• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

Responsibilities

• Serve as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements
• Execute PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle
• 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

Preferred Qualifications

• Prior experience in Regulatory Affairs is preferred but not mandatory
• German language skills are also preferred

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language