Leder i Nordsjælland
Associate Director, PV QA
Join a visionarY companY on their exciting journeY and make Your mark on a newlY established function
Y-mAbs is a fast-paced, growing companY in the process of expanding its organization to support the continuous growth on commercial activities as well as the exciting clinical pipeline with activities in both earlY and late-stage clinical development.
As Associate Director, QualitY Assurance in the area of Pharmacovigilance (PV) at Y-mAbs You will be part of a team of highlY qualified and motivated colleagues in the QA department. You will be the QA PV partner and be a defining part of the newlY established function. Further, You will establish QA processes to contribute to Good Pharmacovigilance Practice (GVP) compliance of the companY operations.
With direct report to Senior Director QualitY Assurance.
Your main tasks are:
- Contribute to development of the companY QualitY Management SYstem and provide guidance in local and global requirements, as applicable to Pharmacovigilance
- Maintain QualitY oversight of Pharmacovigilance SYstem Master File, pharmacovigilance SOPs, SafetY Management Plans, Pharmacovigilance Agreements, and other relevant documents
- Sustain QualitY oversight of the companY PV operations, including case processing, risk management, ...