Shweta Kitture
Assistant Manager, Regional Pharmacovigilance @Cipla
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WORK HISTORY
Assistant Manager, Regional Pharmacovigilance @Cipla
Deputy Pharmacovigilance Officer In-Charge (PvOI)- India To set up the Pharmacovigilance system in different regions according to the national PVguidelines To have an oversight on regional QPPVs/LRPs for the monitoring of pharmacovigilance activities Coordinate with regional QPPVs/LRPs for daily Pharmacovigilance activities Prepare the Pharmacovigilance master file (PSMF) according to country requirements To perform Regulatory Intelligence activity for MHRA, EMA, EUMS To perform QMS related activities i.e to initiate Deviation and CAPA in Track-wise Coordinate with business partners/licensing partners for finalisation of PV agreements, training ofpartners, reconciliation of AEs as per SOP Coordinate with BD to understand the business arrangement and status on commercialagreements and draft the agreement as per the business arrangement Negotiate with the partners for SDEA sign off To update and maintain Master list of business partners/licensing partners To maintain of trackers as per SOP To Update product list and sharing with business partners/licensing partners To Performing reconciliation with the business partners/licensing partners Completion of PV agreements as per relevant SOPs/Wis Performing periodic reconciliation with business partners Training of stakeholders, vendors
EDUCATION
Bharti vidyapeeth collage of Pharmacy, Kolhapur
Bachelor of Pharmacy - BPharm
C.U.Shah College of Pharmacy
M Pharmacy
ABOUT SHWETA KITTURE
Assistant Manager, Regional Pharmacovigilance
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