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. Robust pharmacovigilance knowledge, problem-solving ability, and a proactive, quality-driven approach are essential for success in this role.

ESSENTIAL DUTIES AND RESPONSIBILITIES:



Our employees are tasked with delivering excellent business results through the efforts of their teams.
These results are achieved by:
• Provides support to line managers in activities relating to management of medical review team
• Develop materials (slides, etc.) for Safety Management Team (SMT)/Pharmacovigilance committee (PVC) or Safety Data Review meetings and provide input into recommended safety actions
• Oversee the adjudication and analysis of signal detection outputs, quality assurance of synthesized key safety information; development and continuous improvement of signal detection evaluation and tracking tool
• Lead signal management and benefit risk evaluation (i.e., PBRER) • Provide medical and pharmacovigilance leadership at safety leadership meetings
• Serves as the Lead for several compounds and oversees the operational execution of all safety- related clinical trial activities
• Provides support in the strategy and authoring of integrated submission doc

📌 Lead- Medical Reviewer (India)
🏢 EVERSANA
📍 India