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Associate Director, Safety
Posted 8 days 10 hours ago by Proclinical Group
Permanent
Full Time
Other
Hertfordshire, Welwyn Garden City, United Kingdom, AL7 1
Job Description
Join a cutting-edge pharmaceutical team where your precision and passion for drug safety will help shape the future of life-saving medicines!
Proclinical is seeking an Associate Director to provide safety science and pharmacovigilance expertise across a diverse portfolio. In this role, you will play a pivotal part in ensuring patient safety by leading safety oversight activities, managing risks, and contributing to both early and late-phase development. This is an exciting opportunity to influence healthcare outcomes while working in a collaborative and dynamic environment.
Responsibilities:- Provide oversight and input across all stages of study management, from development through post-market.
- Lead post-market safety activities, including signal evaluation, benefit-risk assessments, and safety risk management.
- Manage individual and aggregate case reporting, including key activities such as DSUR and PBRER preparation.
- Drive signal detection and management, contributing to strategic safety assessments and drug safety reports.
- Influence product safety strategies and provide drug safety input into clinical development plans.
- Prepare and maintain safety documents, including CCDS, IB, risk communications, RMP, and REMS.
- Act independently with minimal supervision, demonstrating strong self-leadership and initiative.
- Advanced degree in life sciences (e.g., PhD, MSc) or a medical qualification (e.g., PharmD) is preferred.
- Strong understanding of GxP-regulated processes and the clinical trial lifecycle.
- Excellent written and verbal communication skills, with the ability to collaborate effectively with global teams.
- Proficiency in analysing and interpreting complex scientific data, with strong presentation skills.
- Proven ability to work independently, manage safety responsibilities, and support safety science activities.
Proclinical Group
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