Description

You will provide safety science and pharmacovigilance support across the Revolution Medicines portfolio, overseeing clinical study safety and contributing to regulatory documents. You will conduct signal detection, risk management, and collaborate with cross-functional teams to ensure patient safety in oncology drug development.

Requirements

• Relevant postgraduate qualification (MD, PharmD, PhD/MSc in Life Sciences)
• 3+ years drug development experience, at least 1 year in drug safety
• Proven success in cross-functional relationship building
• Understanding of safety science, PV (GVP, GCP), and risk management
• Strong presentation and organizational skills

Responsibilities

• Proactive medical safety surveillance of clinical trials for signal identification
• Prepare and present safety data summaries to stakeholders
• Medical review of ICSRs and routine safety data
• Contribute to regulatory documents (protocols, IBs, ICFs, DSURs, RMPs, CCDS, labelling)
• Conduct signal detection and evaluation for benefit-risk assessment