Local Contact Person for Pharmacovigilance and Regulatory Affairs - Remote

Overview

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs 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 and expert advice.
• Collection and reporting of locally suspected adverse drug reactions.
• Local management of risk minimization measures.
• Preparation of documentation for submissions to regulatory authorities.
• Review of local product information.
• Implementation of local pharmacovigilance systems.
• Maintain accurate records and documentation.
• Support audits and inspections.

Requirements

• Bachelor's Degree in Life Sciences or equivalent.
• Minimum 3 years in pharmaceutical or CRO industry.
• Minimum 2 years in a pharmacovigilance role.
• Pharmacovigilance training or experience.
• Expert knowledge of ICH GVP and local regulations.
• Proficiency in English, Czech, and Slovakian.
• 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 with international colleagues.