Job Description
THE POSITION: The Medical Review Lead (MRL) is responsible for supporting the timely and compliant execution of product surveillance activities for client projects. The role involves oversight and contribution to aggregate reports (PADERs, PBRERs), Risk Management Plans (RMPs), signal detection, PLLR, and annual literature reviews, ensuring alignment with regulatory requirements. The MRL serves as a Subject Matter Expert (SME) in medical review and ICSR management, providing scientific inputs, performing quality review, authoring key sections of PV documents, and addressing regulatory queries. Additionally, the role supports project management activities, documentation, and cross-functional collaboration. The position also contributes to new business initiatives by offering medical expertise and supporting SME onboarding. Strong pharmacovigilance knowledge, problem-solving ability, and a proactive, quality-driven approach are essential for success in this role.
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