Local Contact Person Pharmacovigilance (LCPPV) - Freelance - PT Poland

We’re building a local network of talented PV experts to collaborate with on future projects. We’d love to connect with professionals who are interested in staying in touch for freelance (parttime) opportunities. Let’s start the conversation and build a connection! Currently we are looking to add people to our network in Poland.

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of post-marketing regulatory requirements to ensure continued safety and availability of life-changing therapies for patients around the world. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.

The role The Local Contact Person for Pharmacovigilance (LCPPV) coordinates and performs the logistical aspects of pharmacovigilance activities in post-marketed programs to ensure compliance with local requirements. This position controls and monitors operational pharmacovigilance activities and may back-up Pharmacovigilance Manager(s) as required.

Main responsibilities: • 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