Pharmacovigilance

−Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures−Ensure compliance of operations with governing regulatory requirements−Create, maintain and assume accountability for a culture of high customer service.−Execute drug safety data management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, call intake, case follow-up, report preparation and submission to regulatory authorities−Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search−Assume responsibility for quality of data processed

−Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures−Ensure compliance of operations with governing regulatory requirements−Create, maintain and assume accountability for a culture of high customer service.−Execute drug safety data management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, call intake, case follow-up, report preparation and submission to regulatory authorities−Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search−Assume responsibility for quality of data processed

➢ Receiving Serious Adverse Event (SAE) forms, Identification of Adverse events.➢ Performing initial checks of adverse event forms and duplicate search in safety database.➢ Performing case initiation in the database and maintaining track in tracking tool.➢ Assessing priority to cases i.e. Immediate/Licensee Exchange/High/Medium/Low using medical judgments.➢ Case processing of clinical, solicited and spontaneous cases in safety database (Case processing– ARISg 6.3 and 6.6 Database).➢ Effective communication with the client in context to any discrepancies related to cases.➢ Assessing expectedness of adverse event using IB/Protocol/SPC/CDS/DCSI/Local Labeling documents.Identifying potential SUSAR’s.➢ Using medical dictionaries (MedDRA) to code medical history, drugs and AE terms.➢ Writing narratives to summarize essential details of the case.➢ Raising queries to Safety Responsible personnel for missing information.➢ Adhering to regulatory timeline, compliance and quality of cases.

To maintain Ethics Committee documentation (EC approvals, submissions, & notifications).To maintain Trial master file & Pharmacy File.To report all Adverse Events & serious adverse events reports (SAE reports) to Ethics Committee.To maintain patient files and their reports. To fill the EDC or eCRF of patients.To instruct the patient about medication. To plan patient visits as per protocol.Maintaining all inwards and outwards documents of study. Clinical Trial participation:Type II Diabetes mellitus Phase 2, Phase 3 clinical trials.Investigator Meeting:Attended Asia Pacific Investigators Meeting of PAREXCEL at Hong Kong on 5 may 2011.Attended Investigators Meeting of Pharmanet at Mumbai on 16 Sep 2011.Attended Investigators Meeting of Eli Lilly at Bangalore on 12 Nov 2011.