Senior PV Scientist - Contract - Outside IR35
CK Group are recruiting for Senior Safety Scientists to join a pharmaceutical company based in Welwyn on an initial 12-month contract basis - outside of IR35.
Company: This company is one of the world's largest biotech companies and is a leadingprovider of cancer treatments and in vitro diagnostics.
Location: The Senior Safety Scientists in Pharmacovigilance position will be remote based. The offices are easily reachable by road (A1M) and also by rail (25 mins from Kings Cross), if youwere required to visit the office for a meeting.
Senior Safety Scientist Role: The main purpose of the role will be to:
- Support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management.
- Perform signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
- Take responsibility for individualand aggregate case reporting activities including ICSR case management and aggregate reporting.
Further responsibilities will include:
- Contributing to risk management activities including preparation and maintenance of CCDS, labelling documentmaintenance, and risk communications.
- Contributing to study management from a safety perspective and document review and maintenance across the development continuum.
- Contributing to regulatory authority by reviewing safety data and preparingrelevant sections of the filing and submission packages in consultation with SSL and PCS Team Lead.
Your Background: To succeed in this role, you will have:
- A Life Science background and previous industry experience in Pharmacovigilance.
- Understanding of GxP and regulated processes and end to end clinical trial lifecycle.
- Understanding of project management methodology.
Apply: For more information or to apply for the Senior Safety Scientists position, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org, quoting job ref 49896.
It is essential that applicants hold entitlement to work in the UK.