Local Contact Person Pharmacovigilance (Freelance, Poland)

Job summary

The Local Contact Person for Pharmacovigilance (LCPPV) is responsible for coordinating and managing the logistical aspects of pharmacovigilance activities in post-marketing programs to ensure compliance with local regulations. This role serves as the primary liaison with local regulatory authorities and oversees operational pharmacovigilance tasks.

Qualifications

• University degree in medicine, pharmacy, or life sciences.
• Minimum of 2 years of experience in pharmacovigilance post-marketing activities.
• Up-to-date knowledge of global and local regulatory requirements.
• In-depth understanding of the pharmacovigilance legal framework in the relevant country.
• Fluency in written and spoken English.
• Residency in the country where services are provided, if required.

Responsibilities

• Serve as the main point of contact for local regulatory authorities, including 24/7 availability if legally mandated.
• Monitor safety issues and regulatory recommendations related to client products.
• Stay informed about changes in local pharmacovigilance legislation.
• Assist with client audits and inspections, including documentation and CAPA completion.
• Conduct local literature screening and collect safety information.
• Support the development or review of the local pharmacovigilance system master file (LPSMF).
• Manage local risk minimization measures as necessary.
• Report to and communicate regularly with the EU QPPV.
• Provide local PV training to relevant personnel.
• Submit monthly activity reports on the local PV system status.

Skills

• Strong organizational and communication skills.
• Ability to work collaboratively with various stakeholders.
• Detail-oriented with a focus on compliance and safety.

Education

• Degree in medicine, pharmacy, or life sciences.

Tools

• Familiarity with pharmacovigilance databases and reporting tools.