Local Contact Person for Pharmacovigilance – Freelance
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Job Description
Freelance LCPPV coordinating local pharmacovigilance compliance and safety activities. Supporting post-marketing programs for Allucent’s biopharmaceutical clients.
Responsibilities:
- Act as the primary point of contact for local regulatory authorities, including 24/7 availability if legally required
- Monitor safety issues and recommendations published by local regulatory authorities concerning client products or product classes
- Monitor changes to local pharmacovigilance legislation
- Support client audits and inspections, including attendance, documentation provision, and CAPA completion
- Perform local literature screening and collect safety information
- Assist with development or review of the local pharmacovigilance system master file (LPSMF)
- Support local signal detection
- Manage local risk minimization measures
- Report to and maintain regular communication with the EU QPPV
- Support review of local pharmacovigilance agreements
- Deliver local pharmacovigilance training to sales forces, affiliate personnel, and distributors
- Provide monthly activity reports on the status of the local pharmacovigilance system
Requirements:
- University degree, preferably in medicine, pharmacy, or life sciences
- Minimum 2 years of experience performing post-marketing pharmacovigilance activities
- Up-to-date knowledge of applicable global and local regulatory requirements
- In-depth knowledge of the pharmacovigilance legal framework in the country where LCPPV services are delivered
- Fluency in written and spoken English
- Residence in the country where LCPPV services are delivered, if required
Benefits:
- Freelance (part-time) opportunities
- Opportunity to collaborate on future projects
- Opportunity to build professional connections with Allucent
- Opportunity to contribute to the development of new pharmaceuticals and biologics
- Opportunity to work with science, business, and operations leaders
- Growth opportunities
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