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, focusing 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. Right to work in this location is required.

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.

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.

Skills

• 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.