Cpl Life Sciences

Senior Safety Scientist

Central London / West End
£40,000 - £59,999
30 Apr 2021
30 May 2021
George Danchie
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Senior PV Scientist
Salary: Up to 65,000 + benefits

Are you a Senior PV/Safety Scientist looking for a new opportunity?

We have a new requirement for an experienced Senior PV/Safety Scientist to join a global biotech company on a permanent basis in London.

As a Senior PV/Safety Scientist, 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.

Key Responsibilities:

- 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

Experience Required:

- Minimum 4 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

This is an excellent opportunity to work for a growing, global business with a strong product pipeline. The successful applicant will be rewarded with a competitive salary and benefits including bonus and flexible home working.

If you are interested in this role, please feel free to call George on 0118 959 4990 or send your cv to George.Danchie@cpl.com

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