Mukesh Mandal Email & Phone Number

1. Accountable for handling ICSRs, EDC alerts, extracting data from e-Madidata Rave, Notification to sponsor, disposition of valid items from E2B, case importing and triaging.2. Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures. 3. Case processing, Safety narrative writing and Query Escalation handling, ensured the accuracy of coding of AE and suspects along with its indication using MedDRA, company product dictionary and WHO‐DD.4. Responsible for generating and forwarding appropriate queries and request for clarification of discrepant data or additional data.5. Quality reviewing of cases, train data entry team in order to ensure highest quality, provide the feedback to the data entry team members for the errors noted and quality improvement of the process, finalization of cases.6. Workflow Manager Activities, manage workflow, ensure meeting deadlines, preparation of monthly Volume and KPI metrics, SAEs Reconciliation7. TMF filling, preparing case file for TMF filling according to the sponsor guidelines.8. Efficiently handled various sponsor mailbox, ensuring that the cases are evenly distributed among resources and processed in time. Trained and supported new resources to get maximum utilization and contribution to project from them.

Listed skills include Leadership, Conflict Management, Team Building, Social Media, and 16 others.