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.
Please note that to be considered for this role you must have the right to work in this location.
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.
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