CK Group are recruiting for a Medical Devices Clinical Safety to join a company in the pharmaceutical industry on a contract basis for 6 months.
Salary:
Up to £33.58 per hour PAYE, or to £45 per hour Ltd/Umbrella (outside IR35)
Medical Devices Clinical Safety Role:
* The primary responsibility of this role is to support clinical investigations of MDs by developing and providing safety input into core MD clinical investigation documents, including the Clinical Investigation Plan (CIP/Protocol), Investigator’s Brochure (IB), and Reference Safety Information (RSI).
* The role holder is expected independently and strategically to lead the development of safety deliverables for MD clinical investigations.
* The role holder will provide MD safety expertise and support across all safety-related aspects of medical devices.
* The individual must be able to collaborate effectively within multifunctional and multicultural teams and is expected to work independently, demonstrating strong self-leadership.
Your Background:
* Medical Device (MD) clinical safety background,
* experience with the MD benefit/risk assessment and MD risk management, particularly in safety-related aspects.
* Furthermore, expertise in safety activities related to MD clinical investigations or studies involving MDs, with familiarity with relevant ISO standards (eg, ISO 14155) would be important.
* Experience with combination products (drug/MD combination) and/or with some additional background in drug safety would also be considered strong assets.
Company:
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Location:
This role is based at our clients site in Welwyn Garden City, but can be hybrid or remote for the ideal candidate.
Apply:
For more information, or to apply for this Medical Device Clinical Safety role please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 163 534.
It is essential that applicants hold entitlement to work in the UK
Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.