Conduct signal management activities for assigned products and performing signal alerts in lifesphere signal management system.Preparation and review of aggregate reports including PSUR, PBRERS, PADERs,Annual reports, DSURs and ACOs.Preparation of RMPs and contribute to REMS activities.Preparation of Health Hazard Evaluation (HHEs) reports and other adhoc safety reports.Scheduling of aggregate report calendars for PBRERs and PADERsConducting benifit risk evaluations with Drug safety PhysiciansRegulatory Authority Query Management: Responding to PV related regulatory Authority queries and providing the response by coordinating with various stake holders.

• Preparation and review of signal reports. • Support the medical lead in the analysis and preparing of signals and signal evaluation reports for all sponsor products for all entities. Co-ordinate with the lead medic in organizing and conducting the safety review meetings. Monitor different regulatory authority websites for new signals. • Perform literature search for the products post Data Lock Point (DLP) and review of the literature hits for safety information. • Generate line listings from the safety database as per the review period and incorporate the data in the signal report. • Preparation and/or review of PADERS, PBRERS, PSUR and CAR as per SOP and coordinate with cross functional teams including vendors for the completion of report on timeline with quality. • Support the team in responding to health authority queries

Drafting Canada summary reports, ACO's and PSUR's for all the regions.• Assisting in the management of ACO's and PSUR's for all the regions..• Management of legacy data migration..• Submission of ICSR expedited and periodic safety reports (PADERS, PSURS) to HealthAuthorities in stipulated timelines without any non-compliance.• As a global submissions expert, ensures the team has sufficient awareness and knowledgeof e-submissions.• Maintain tracking of safety submissions and submission status updates as required.• Assists in the tracking and measuring of program/project and team progress throughcollection of cycle time metrics and other key performance indicators (KPIs), related tosubmission.

• Intake, Triage, Data entry of ICSRs.• Responsible to review the documents disposed and perform full data entry of individualcase safety reports (ICSR) into the safety database including confirmation of duplicatecheck.• Review and evaluate AE case information to determine required action based on andfollow internal policies and procedures.• Write the narrative in a chronological order by using the respective available templateswith the information reported without spelling and spacing errors.• Assess the reporter causality as per the reporter comments from the source documents foreach Product - Event basis if not auto-populatedfrom IRT.• Assess the Listedness for the Adverse Events Reported based on the Reference SafetyInformation (RSI) or Company Core Data Sheet (CCDS).• Perform validation check to ensure no important AE information is missed to enter in theDatabase.