A Pharmacovigilance Manager is responsible for overseeing the monitoring and reporting of adverse effects and safety concerns related to pharmaceutical products - Freeland, United States - NebulaWorks

NebulaWorks

Verified Company

Freeland, United States

21 hours ago

Posted by:

Meredith Sinclair

beBee Recruiter

Description

Pharmacovigilance Manager (m/f/d) We are looking for Pharmacovigilance Managers with potential for development to become Stufenplan-Beauftragte/QPPVs (m/f/d) Full-time, with professional experience, Leipzig, Pharmacovigilance, permanent, starting immediately About us We, GmbH, are a biopharmaceutical company and manufacturer of cell transplants.

Our focus is on the development and production of cell therapies for joint-preserving treatment of cartilage defects using exclusively autologous cartilage cells.

The method we offer is used in over 200 clinics and has already been used in over patients.

Currently, we are active with two locations in Germany as well as with subsidiaries or distribution partnerships in Switzerland, the Netherlands, Great Britain, and Austria.

Website:
Your tasks Processing of case reports on adverse reactions, including tissue vigilance cases, and reporting to authorities Evaluation of potential risks within the risk management team and implementation of measures Coordination and preparation of periodic safety reports Monitoring of signal management Creation of the PSMF Conducting PV trainings Conducting and evaluating literature searches Creation of relevant SOPs and forms Participation in pharmacovigilance audits and inspections Compliance management including reconciliation with internal and external departments Complaint management Support in contract management (PVA, SDEA) Close cooperation with regulatory affairs, production, quality assurance, and external service providers Perspective Takeover of the function of Stufenplan-Beauftragter (