THE POSITION:
This position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data compilation from clinical trials and spontaneous post-marketing reports and other sources.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
 Plays an essential role supporting PV Operational Delivery to facilitate and meet client project deadlines for various aggregate and signal reports, line listings, and safety data compilation as required by client.
 Manages the operational aspects of aggregate safety reporting. Provides pharmacovigilance data analysis, authoring, and quality control (QC) expertise for the preparation of a range of global regulatory aggregate safety reports to include Periodic Adverse Drug Experience Reports (PADER),



Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR) / Periodic Benefit Risk Evaluation Reports (PBRER), Annual Safety Reports (ASR), and IND Annual Reports and client specific signal detection reports.
 Lead, author and finalize aggregate reports and cumulative, or ad hoc, line listings as required to meet regulatory requirements and contracted deliverables for client projects
 Support the authoring and editing of RMP, PSMF, and/or other PV risk management documents in collaboration with PV safety science, PV operational leadership, and PV Project Management  Collaborates with various stakeholders to ensure that outputs from the safety database meets the need for preparation through submission of aggregate safety reports, while maintaining compliance with regulatory timeline(s).
 Thorough understanding and adherence to aggregate safety reporting processes and procedures, safety mana

📌 Safety Writing Specialist (India)
🏢 EVERSANA
📍 India