Local Contact Person for Pharmacovigilance (Freelance, Remote)

Job summary

This role involves coordinating and managing the logistical aspects of pharmacovigilance activities for post-marketing programs, ensuring compliance with local regulations. The position serves as the primary contact for local regulatory authorities and supports various pharmacovigilance functions.

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, available 24/7 if legally required.
• Monitor safety issues and recommendations from local regulatory authorities regarding client products.
• Stay informed about changes to local pharmacovigilance legislation.
• Assist with client audits and inspections, including documentation and corrective actions.
• Conduct local literature screening and gather safety information.
• Support the development or review of the local pharmacovigilance system master file.
• Manage local risk minimization measures as necessary.
• Report to and communicate regularly with the EU QPPV.
• Review local pharmacovigilance agreements as requested.
• Provide training on pharmacovigilance to relevant personnel.
• Submit monthly activity reports on the status of the local pharmacovigilance system.

Skills

• Strong organizational and communication skills.
• Ability to work independently and manage multiple tasks effectively.

Education

• A degree in a relevant field such as medicine, pharmacy, or life sciences is required.

Tools

• Familiarity with pharmacovigilance databases and reporting tools is advantageous.