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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.
Key Skills and Requirements:
  • 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.
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