Director Safety Scientist

Job Title: Director Safety ScientistLocation: Welwyn, with Hybrid workSalary: competitive market salaryType: PermanentCK 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 ..... full job details .....
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