At a Glance
- Tasks: Lead safety oversight and manage risks in drug development.
- Company: Join a cutting-edge pharmaceutical team dedicated to life-saving medicines.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Other info: Exciting role with minimal supervision and strong self-leadership opportunities.
- Why this job: Make a real impact on healthcare outcomes while collaborating with global teams.
- Qualifications: Advanced degree in life sciences or medical qualification preferred.
The predicted salary is between 70000 - 90000 Β£ per year.
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., Ph D, MSc) or a medical qualification (e. g., Pharm D) is preferred.
Strong understanding of Gx P-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. #J-18808-Ljbffr
Associate Director, Safety employer: Proclinical Group
Proclinical Group is an excellent employer, offering a dynamic work culture that fosters collaboration and innovation in the field of diagnostic technologies. Employees benefit from comprehensive training programs, opportunities for professional growth, and the chance to make a meaningful impact on customer satisfaction and business success in the vibrant location of Croydon, UK.