At a Glance
- Tasks: Lead global drug safety strategy and oversee safety assessments for innovative products.
- Company: Join a pioneering R&D firm dedicated to advancing drug safety.
- Benefits: Competitive salary, comprehensive health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and compliance.
- Why this job: Make a significant impact on global health by ensuring drug safety throughout product lifecycles.
- Qualifications: Medical Degree and 10+ years in clinical safety leadership required.
The predicted salary is between 100000 - 150000 £ per year.
Shape the future of drug safety with expert leadership across global development and post-market phases. R&D Partners is seeking a Director of Clinical Drug Safety & Physician to provide strategic safety leadership across multiple programs or therapeutic areas. This role is pivotal in ensuring the safety profile of assigned products throughout their lifecycle, from pre- to post-marketing surveillance, in compliance with global health authority regulations.
Responsibilities
- Lead global safety strategy for program teams, ensuring data-driven review and assessment.
- Oversee safety signal detection and benefit-risk assessments for assigned products.
- Represent global safety at cross-functional meetings on development projects and studies.
- Collaborate with cross-functional teams (e.g., Biostatistics, Clinical, Regulatory Affairs) to develop risk management strategies for safety signals.
- Provide senior medical safety leadership in governance forums, including Safety Review Committees and Data Monitoring Committees.
- Author and update aggregate safety reports, regulatory safety submissions, and safety sections of filings.
- Participate in the development of safety-related data collection standards for clinical studies.
- Confirm regulatory submission assessments and approve SUSARs before submission.
- Provide medical review of Serious Adverse Event reports to ensure timely regulatory submissions.
- Ensure compliance with global pharmacovigilance regulations (e.g., CIOMS, EMA, FDA, ICH).
- Contribute to safety process improvements and best practices across the organization.
- Participate in regulatory inspections and internal audits.
Key Skills and Requirements
- Medical Degree (MD or MD-PhD) required.
- Minimum 10 years of industry experience in clinical safety with leadership responsibilities.
- Strong understanding of global pharmacovigilance principles, regulatory requirements, and MedDRA coding.
- Expertise in signal detection, evaluation, and aggregate data analysis in clinical trials.
- Excellent analytical and critical thinking skills for evaluating complex medical data.
- Strong communication and collaboration skills to interact effectively with cross-functional teams.
- Proven ability to prioritize and deliver results within aggressive timelines.
- Experience authoring safety-related documents, including protocols, IBs, ICFs, and RMPs.
Director of Clinical Drug Safety & Physician in London employer: R&D Partners
R&D Partners is an exceptional employer that prioritises employee development and fosters a collaborative work culture. With a focus on innovation in the healthcare sector, we offer comprehensive training programs and opportunities for career advancement, all while supporting our team with flexible travel arrangements. Join us in making a meaningful impact in medical diagnostics and enjoy the unique advantage of working alongside passionate professionals dedicated to improving patient care.
