Local Contact Person for Pharmacovigilance – Freelance

🔥 0 minutes ago

🌐 Poland, Finland, +4 more countries – Remote

🇵🇱 Poland – Remote 🇫🇮 Finland – Remote 🇳🇴 Norway – Remote 🇸🇪 Sweden – Remote 🇮🇸 Iceland – Remote 🇩🇰 Denmark – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

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Allucent

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.

📋 Description

• 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