Pharmacovigilance (LCPPV) - Freelance

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Requirements:

• University degree, preferably in medicine, pharmacy, or life sciences.
• Minimum 2 years of experience in pharmacovigilance post-marketing activities.
• Up-to-date knowledge of global and local regulatory requirements.
• In-depth knowledge of the pharmacovigilance legal framework in the service country.
• Fluency in written and spoken English.
• Must reside in the country where LCPPV provides services.

Responsibilities:

• Acts as the primary contact for local regulatory authorities, including 24/7 availability if legally required.
• Monitors local legislation and safety issues related to pharmacovigilance.
• Supports audits and inspections, providing documentation and completing CAPAs as needed.
• Involves local literature screening, safety information collection, and local submissions.
• Responsible for local signal detection and managing risk minimization measures.
• Reports to and communicates regularly with the EU QPPV.
• Conducts local PV training and provides monthly activity reports on the local PV system.