CK Group are recruiting for a Senior Safety Physician to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 6 months.
Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.
This Senior Safety Physician role will be based at our clients site in Cambridge.
£800-990 per day LTD, depending on experience.
Senior Safety Physician Role:
- Responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level.
- Responsible for the continued safety assessment, evaluation and risk management of products or product groups in various stages of clinical development and/or the post-marketing setting.
- Responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements.
- Responsible for consistent communication of safety topics across all regulatory safety documents, eg. Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs). for assigned product(s)/programs(s).
- Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.
- Medical degree (e.g. MD, MBBS).
- At least 2 years of clinical experience post-registration.
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
- At least 5-7 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
- A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements (eg BLA, NDA or MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities.
For more information or to apply for this Senior Safety Physician position, please contact CK Group, quoting job ref 50731.
It is essential that applicants hold entitlement to work in the UK.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Dennis Beltman
- Phone: 01438 870027
- Reference: 50731
Website: CK Group
- Posted: 26th May 2021
- Expires: 23rd June 2021