Local Contact Person, Pharmacovigilance – Freelance, PT

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Allucent

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

• Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required • Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class • Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance • Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed • Performs local literature screening and collection of safety information • Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required • Supports local signal detection, if applicable • Manages locally risk minimization measures, as applicable • Reports to and maintains regular communication with the EU QPPV • Supports the review of local PV agreements, if requested • Performs local PV training to eg. sales force, affiliate personnel, distributors • Provides monthly activity report on status of local PV system

🎯 Requirements

• University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post-marketing activities • Have up-to-date knowledge of applicable global and local regulatory requirements • In-depth knowledge of the pharmacovigilance legal framework in country where LCPPV services are delivered • Fluency in the written and spoken English language • Reside in the country where LCPPV provides services, if required

🏖️ Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/office-based* working depending on location • Leadership and mentoring opportunities • Participation in our enriching Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees