Job DescriptionJob Title: Director Safety Scientist
Location: Welwyn, with Hybrid work
Salary: £competitive market salary
Type: Permanent
CK Group are recruiting for a Director Safety Scientist, to join a growing global pharmaceutical company, on a permanent basis, in Welwyn, Hertfordshire, UK.
Director Safety Scientist will require you to:
* Provide safety science and pharmacovigilance support across the drug development lifecycle, from early-phase trials to post-marketing.
* Develop and maintain a deep understanding of the safety profile of assigned products or therapy areas.
* Lead and contribute to signal detection and management activities.
* Oversee safety-related documents including CCDS, RMPs, REMS, DSURs, and PBRERs.
* Act as a key safety contributor on study teams and within global regulatory submissions (INDs, NDAs, MAAs, variations, renewals).
Further Responsibilities will include:
* Reviewing and medically assessing individual and aggregate case safety reports.
* Supporting labelling document updates and risk communication strategies.
* Participating in study teams and cross-functional safety discussions, including input on study protocols and post-authorization safety studies (PASS).
* Ensuring compliance with quality systems and applicable global regulations.
Your Background:
* A degree in a healthcare or life sciences discipline is required; a postgraduate qualification (e.g. MSc, PharmD, MD, PhD) is .
* Significant experience in pharmacovigilance, clinical development, or medical affairs within the pharmaceutical industry.
* Strong understanding of GxP standards, global regulatory requirements, and safety reporting frameworks.
* Experience with signal management systems, regulatory safety submissions, and drug safety databases.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 140 666 in all correspondence.
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