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, health benefits, and opportunities for professional growth.
- Other info: Dynamic environment with opportunities for self-leadership and initiative.
- Why this job: Make a real impact on healthcare outcomes while working collaboratively.
- Qualifications: Advanced degree in life sciences or medical qualification preferred.
The predicted salary is between 70000 - 90000 £ 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.
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Associate Director, Safety in Welwyn Garden City 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.
