PV Manager Risk Management & Medical Surveillance
London / Remote
Salary: Up to 75,000 + benefits
Are you a Pharmacovigilance Manager with safety scientist experience looking for a new opportunity?
We have a new requirement for an experienced PV Manager with a strong safety science background to join a global biotech company on a permanent basis.
As a PV Manager, you will utilise your scientific expertise to report on the development of pre and post marketed drug products. You will work cross-functionally with PV Physicians, Clinical Development and Regulatory teams to conduct safety surveillance activities, signal detection and evaluation, development of aggregate reports and risk management plans.
- Support global risk management activities, including development of procedural
- Development of aggregate reports including PSURs, DSURs, PBRERs, RMPs
- Provide input with regulatory submission documents and interactions with global
regulatory agencies, and interactions with external partners
- Lead resolution of safety issues and facilitate cross-functional agreements.
- Responsibility for Signal Detection activities
- Preparation of safety-related materials for clinical and regulatory documents such as
clinical study reports, IBs, Study protocols, RMPs and responses to Health Authority
- Minimum 5 years working within/leading Safety Science/PV Risk Management within
pharma or biotech
- Safety Surveillance and Signal Detection experience
- Experience with both drug development and post-marketed products
- Advanced knowledge of global PV regulations
- Excellent written and verbal communication skills
- Oncology experience preferred
This is an excellent opportunity to work for a growing, global business with a strong product pipeline. If this role is of interest, please send your CV to Hanna.Poole@cpl.com or call 0118 952 2793 for more information.
- Agency: Cpl Life Sciences
- Contact: Hanna Poole
- Reference: JO-2109-476127
Website: Cpl Life Sciences
- Posted: 13th September 2021
- Expires: 11th October 2021