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, executing PV and RA activities at the local level.

In Short

• Primary contact with local regulatory authorities for compliance.
• Effective communication with local regulatory authorities.
• Provision of local regulatory intelligence and expert advice.
• Collection and reporting of locally suspected ADRs.
• Local management of risk minimization measures.
• Preparation and collection of documentation for submissions.
• Review of local Product Information and Mock-ups.
• Development of local pharmacovigilance systems.
• Maintain accurate records and documentation.
• Support RA & PV Global operations team.

Requirements

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent.
• Minimum 3 years in pharmaceutical or CRO industry.
• Minimum 2 years in LCPPV or relevant pharmacovigilance role.
• Pharmacovigilance training and/or experience required.
• Prior experience in Regulatory Affairs preferred.
• Expert knowledge of ICH GVP and local legislation.
• Proficiency in English and Italian, written and verbal.
• 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 colleagues worldwide.