Pharmacovigilance (LCPPV) - Freelance

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are currently expanding our global PV network and looking for passionate individuals with experience across local pharmacovigilance. The LCPPV coordinates and performs the logistical aspects of pharmacovigilance activities in clinical trials and post-marketed programs to ensure an effective and accurate collection, database entry, review and reporting of safety data for Allucent Pharmacovigilance activities. This position controls and monitors operational pharmacovigilance activities and may back-up Pharmacovigilance Manager(s) as required.

This role can be based in any European Country however you must reside in the local country.

Key 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

Requirements

Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required

Provides a deputy for coverage in case of absence

Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance

Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class

Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed

Also key responsibility for;

• local literature screening
• collection of safety information
• local submissions, if applicable
• the development or the review of the local pharmacovigilance system master file (LPSMF), if required
• local signal detection, if applicable
• Manage locally any risk minimization measures, as applicable
• Report to and maintain regular communication with the EU QPPV
• for review of local PV agreements, if requested
• local PV training to eg. sales force, affiliate personnel, distributors
• Provides monthly activity report on status of local PV system