Sumeet Vyas Email and Phone Number

-Preparation/Review of Aggregate Reports including Periodic Benefit Risk Evaluation Reports(PBRERs)/Periodic Safety Update reports(PSUR) and Addendum to clinical overview(ACOS) -Collection, preparation and finalization of aggregate reports. -Compilation of data for Aggregate Reports including Line listing and Summary tabulation into relevant sectons of periodic report. -Responsible for management and timely submission of aggregate reports in order to achieve 100% compliance.-Mentoring to new joiners about periodic reports drafting as per requirement. -Interact with team members to resolve any issues that arise during reviews.-Work with the team leader to escalate the tasks related to PV activity.

I have completed 2 years in Apcer life sciences,ahemdabad. QC of Screening of literature articles. Validating the cases into categories like Valid , invalid and safety information. Final triage of cases based in country wise, drug, dose strength and duplicate search. Assigning of cases to team. Supporting other teams as well in QC of literature articles.

-Experienced in writing of aggregate safety reports including Periodic Benefit Risk Evaluation Reports(PBRERs)/Periodic Safety Update reports(PSUR) and Addendum to clinical overview(ACOS) -Processing of Individual Case Safety Reports in Safety Database (ARISg) •Case narrative writing and duplicate check of spontaneous and literature cases. • Participate in team meeting and signal detection meetings. • Maintenance of case and literature activity tracker.• Weekly literature search.• Archival of PV activity documents.