Drug Safety Lead

Could your expertise shape the safety profile of tomorrow's breakthrough therapies from development through to global commercialisation? R&D Partners is seeking a Drug Safety Lead to join a leading biotech company. This role focuses on pharmacovigilance and safety monitoring throughout the product lifecycle. The ideal candidate will have a strong background in medical practice, pharmacovigilance, and regulatory compliance, with the ability to work in a fast-paced environment. Please note that to be considered for this role you must have the right to work in this location. Responsibilities: Lead active monitoring and ongoing assessment of the safety profile through systematic signal detection and critical review of aggregate safety data and literature during all product lifecycle phases. Serve as the author and accountable content owner for safety-relevant documents during clinical development (e.g., ICF Risk Language, IB, DSUR, Development RMP) and post-approval (e.g., PSUR, RMPs, responses to Health Authority requests). Develop safety communications such as DHCP letters as needed. Ensure timely delivery of safety deliverables for Clinical Study Reports, market applications, and other regulatory documents. Provide analysis and presentation of safety data in multidisciplinary teams (e.g., Safety Risk Management Teams). Act as the safety expert, providing strategic input to key stakeholders regarding product safety and understanding the medical context of the product class. Collaborate with Safety Risk Management colleagues to align on identifying, evaluating, and communicating safety issues. Key Skills and Requirements: Medical Doctorate (MD) from the US or EU is required. Minimum of 3 years of medical practice experience. At least 3 years of pharmaceutical industry experience as a product/program lead within pharmacovigilance. Experience in clinical research or clinical development is a plus. Strong knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools/processes, and relevant regulatory frameworks. Sound clinical acumen and broad therapeutic area knowledge. Proficiency in synthesizing and analyzing safety data from various sources. Expertise in international regulations governing drug safety and experience managing compliance through audits and inspections. Working knowledge of FDA, EU, and ICH guidelines and regulations for safety reporting in clinical trial environments. Excellent communication skills, including medical/scientific writing. Strong interpersonal, decision-making, and influencing skills. Ability to work effectively in a fast-paced environment with tight deadlines. For more information, please contact William Tyler. #J-18808-Ljbffr R&D Partners