Director, Safety Science
3 Days Old
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Providing growth phase Biotech & Pharma companies access to leading talent across Clinical, Patient Safety & Medical Affairs
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).
- Significant experience in pharmacovigilance, clinical development, or medical affairs within the pharmaceutical industry.
- In-depth knowledge of GxP, clinical trial processes, and regulatory requirements.
- Strong data analysis and scientific communication skills.
- Proven ability to lead projects, mentor teams, and work cross-functionally in a global environment.
- Familiarity with safety databases and signal detection tools is advantageous.
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.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
ResearchIndustries
Biotechnology Research and Pharmaceutical Manufacturing
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#J-18808-Ljbffr- Location:
- London, England, United Kingdom
- Salary:
- £150,000 - £200,000
- Job Type:
- FullTime
- Category:
- Other