Sumit Chinchbankar Email and Phone Number

• A pro-active, passionate and skilled pharmacovigilanceassociate.• Accountable for handling ICSR’s, received via data exchangesystems and disposition of valid items into ARIS from IRT forfurther processing.• Accountable for handling ICSR’s in Agxchange database.• Responsible for retrieving and uploading the sourcedocuments in IRT to created receipt items for all valid casewith adverse event.• Accountable for sending queries for clarification associatedwith incoming information if required.• Accurate data capture of spontaneous and nonInterventional program ICSR.• Able to identity PQC, Special Situations Reports such asMedication error, Lack of efficacy, Missed dose, Diseaseprogression, off label use and Misuse cases process as perSOP.• Well versed with adverse event coding tools like MedDRA.•Safety narrative writing in accordance with conventions.• Responsible for reviewing event description section forspecific compliance statement.• Taking session on quality adherence.• Working as quality SPOC of the team, and maintain differenttrackers with all applicable details and Query resolution ofteam members.• Managed the within team as a back up lead in absence ofteam lead and communicate with team and outside the team.• Actively solving Colleagues queries at time of Caseprocessing.

- To verify and ensure the implementation of all SOP at shopfloor. - To monitor and ensure that the correct practices and procedures are followed during production activity at shopfloor.- To check all daily activities like maintaining daily records.-Line clearance and line certification to batch to batch and product changeover. -To perform the routine calibration and verification of all in process testing instruments.- To perform the in process testing during manufacturing and packing.- Take part in dispensing activity of active Raw material.- Destruction of Expired, Rejected and Non-moving Raw/ Packing material.-To review BMR and BPR at shopfloor to ensure the documentation compliance.