Local Contact Person for Pharmacovigilance and Regulatory Affairs (Freelance) - 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.
• Effective communication with local regulatory authorities.
• Provision of local regulatory intelligence screening.
• Collection and reporting of locally suspected ADRs.
• Local management of risk minimization measures.
• Preparation and collection of documentation for submissions.
• Review and linguistic input on local Product Information.
• Development of local pharmacovigilance system.
• Maintain accurate records and documentation.
• Support audits and inspections.

Requirements

• Bachelor's Degree in Life Sciences or Chemistry.
• Minimum 3 years in pharmaceutical or CRO industry.
• Minimum 2 years in a LCPPV role.
• Pharmacovigilance training and/or experience.
• Expert knowledge of ICH GVP and local regulations.
• Proficiency in English & French.
• Strong skills in Microsoft Office applications.

Benefits

• Training and career development opportunities.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work globally with English as the company language.