Local Contact Person for Pharmacovigilance and Regulatory Affairs - Remote

Overview

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.

In Short

• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance.
• Effective communication with local regulatory authorities.
• Provision of local regulatory intelligence screening and expert advice.
• Collection and reporting of locally suspected ADRs or ICSRs.
• Management of risk minimization measures related to safety issues.
• Preparation and collection of documentation for regulatory submissions.
• Review of local Product Information and Mock-ups.
• Development of local pharmacovigilance system.
• Screening of literature for potential ADRs and safety information.
• Support to the RA & PV Global operations team.

Requirements

• Degree in Pharmacy, Pharmacology or Medical Biochemistry.
• Minimum 3 years within pharmaceutical or CRO industry.
• Minimum 2 years within LCPPV role or relevant pharmacovigilance experience.
• Pharmacovigilance training and/or relevant experience.
• Prior experience in Regulatory Affairs preferred.
• Knowledge of ICH GVP and local regulations.
• Proficiency in at least one of several languages (Dutch, Croatian, Czech, French, German, Italian, Polish, Spanish).
• Strong skills in Microsoft Office applications.

Benefits

• Training and career development opportunities.
• Emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues worldwide.