Job Description
Job Title: Associate Director / Director – Safety Science
Location: UK (Hybrid / Flexible Working Options)
Overview:
Our client, a leading global biopharmaceutical organisation, is seeking experienced Safety Scientists at the Associate Director or Director level to support their dynamic and innovative portfolio.
This role will provide pharmacovigilance and safety science expertise across the entire product lifecycle – from early development to post-marketing – ensuring patient safety and regulatory compliance.
Key Responsibilities:
* Serve as a key member of the safety team, supporting early and late-phase development programs.
* Develop and maintain a comprehensive understanding of the safety profile of assigned products or therapy areas.
* Conduct individual case safety report (ICSR) management, including medical review, and lead aggregate reporting (e.g., DSURs, PBRERs).
* Drive signal detection and management activities, including safety assessments and regulatory responses.
* Contribute to risk management plans (RMPs), core safety documents (CCDS), labelling updates, and safety-related communication.
* Provide safety oversight in clinical study management across all phases, including post-marketing surveillance (e.g., PASS).
* Support regulatory submissions including INDs, NDAs, MAAs, and variations.
* Participate in internal or external safety monitoring committees.
* Collaborate with vendors and cross-functional teams to ensure timely and high-quality safety deliverables.
* Mentor junior colleagues and contribute to continuous improvement of safety science practices.
Experience and Qualifications:
* Life Sciences degree or equivalent healthcare qualification (e.g. MSc, PharmD, PhD preferred).
* 5+ years experience in safety science covering First in Human through to Post Market
* Hands-on experience with aggregate safety reports (DSURs, PBRERs, periodic reports).
* Proven ability in signal detection, evaluation, and management, including safety assessments and regulatory responses.
* Experience contributing to risk management activities (CCDS, product labelling updates, RMPs, REMS, risk communication).
* Involvement in safety oversight of clinical trials (study teams, protocol reviews, safety monitoring committees, and post-authorization safety studies).
* Direct contributions to regulatory submissions (IND, NDA, MAA, variations, renewals) with responsibility for safety data and documentation.
* Strong data analysis and scientific communication skills.
* Proven ability to lead projects, mentor teams, and work cross-functionally in a global environment.
Why Join?
You’ll be part of a purpose-driven team shaping the future of drug safety. Our client offers a collaborative culture, clear career pathways, and the opportunity to work on a diverse, high-impact portfolio across multiple therapeutic areas.