On behalf of my client, a global pharmaceutical company we are working with them on a new opportunity for a PV Physician Manager.
You will provide medical evaluation and support for the Pharmacovigilance operations of all products across the company and affiliate companies for which marketing authorizations are held.
Your role will be to accomplish department objectives by managing staff; planning and evaluating department activities.
The PV Physician Manager (PVP Manager) will be responsible for the medical evaluation of all Company products/projects and will work with the QPPV/Deputy QPPV and other PV Physicians to ensure that medical support is always available within the PV Department.
The PVP Manager will be responsible for medical evaluation of Individual Case Safety Reports (ICSR), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Report (PSUR/RBRER), Annual Safety Reports (ASR), and other safety reports as required.
The PVP will be responsible for detecting, prioritizing and evaluating safety signals, writing the safety section of the electronic CTD (common technical document), providing safety input to project teams as required, producing scientific reports on specific safety issues, and responding to queries (both internal and external) regarding safety issues.
The PVP Manager will be responsible for providing medical input to the Risk Management Plans and performing maintenance activities on assigned products.
At least 1-2 years of clinical practice
Documented experience in pharmacovigilance
Experience in medical evaluation of ICSR, including literature review
Excellent oral and written English communication
Detail oriented, ability to multi-task and work with a high degree of accuracy
For full details email your CV to firstname.lastname@example.org or call Tina at +353 1 2784671
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