Expire in: 24 days
Job 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 preferred.
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 (Apply online only) in all correspondence.
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