THE POSITION:

The position supports Pharmacovigilance department as a key member primarily contributing to leading a team that comprises of aggregate report scientists and physician(s) involved in aggregate report writing and signal detection.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
Lead Medical Review activities and oversee pharmacovigilance operational delivery for aggregate safety reports, signal management activities, and regulatory compliance commitments across multiple client programs. Drive the planning, tracking, and finalization of aggregate reports, signal detection outputs, cumulative analyses, and ad hoc line listings to ensure timely delivery in accordance with global regulatory requirements and client expectations. Provide strategic medical and operational oversight for the preparation and review of key aggregate safety reports including PADERs, PSURs/PBRERs, DSURs, ASRs, IND Annual Reports, Risk Evaluation reports,



and client-specific signal detection and safety governance outputs. Lead medical assessment and review of safety data trends, signal evaluation activities, and benefit-risk analyses to support ongoing product safety surveillance and regulatory decision-making. Support authoring, review, and maintenance of Risk Management Plans (RMPs), PSMFs, Safety Management Plans (SMPs), Pharmacovigilance Agreements (PVAs), and Safety Data Exchange Agreements (SDEAs) in collaboration with Safety Science, PV Operations, Medical Review teams, and Project Management. Act as a key liaison across cross-functional stakeholders including medical reviewers, safety scientists, PV operations, biostatistics, regulatory affairs, and clients to ensure accurate and compliant preparation through submission of aggregate and signal management deliverables. Provide operational and strategic oversight to ensure safety database outputs, med

📌 Medical Director/senior Director (Madhya Pradesh)
🏢 EVERSANA
📍 Madhya Pradesh