Shaifalee Shroff
Senior Drug Safety Associate at Tata Consultancy services (Quality Reviewer | Special situation SME | Product Responsible | Digital Media Associate)
- Role
- Senior Drug Safety Associate at Tata Consultancy Services
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
Experience
Senior Drug Safety Associate
Aug 2019 — Present · Thane, IN
ICSR quality review of all SUSAR cases, clinical cases, compassionate use cases, NIS case, NIP/Spontaneous cases, pregnancy and special situation cases, literature cases, E2B reports (ARISg 7.4). • Analysis of quality metrics for top 5 error trend fields on monthly basis • Preparing presentation for monthly quality metrics• Maintain quality, Meeting compliance of ICSRs as per BP/LP and regulatory timelines and meeting productivity through a metrics based approach. Ensuring that agreed SLA are met as per agreement• Provide inputs and share mails and roll out quiz to entire drug safety for process improvement• Special Situation SME : Solve daily queries of Drug Safety received via mail. Share weekly Special Situation quiz for process improvement• Product Responsible : Product Responsible for 8 Data Handling Guidelines which is reference document/coding guidelines for a particular drug• Digital Media Associate : Contact testing all company as well as non company owned broad casting digital channels (global, local), engaging digital channels, all digital communications and solutions that use to communicate with individual external or public with websites, pages, social media, blogs, webforms, health portals, chatrooms, mobile applications etc. Also engaged in CTV processing.• ICSR cases processing knowledge for SUSAR cases, clinical cases, compassionate use cases, NIS case, NIP/Spontaneous cases, pregnancy and special situation cases
Education
Saint Francis High School
SSC
1999 — 2011
Shreemati Nathibai Damodar Thackersey (SNDT) Women's University, Mumbai
Bachelor of Pharmacy - BPharm
2013 — 2017
Shreemati Nathibai Damodar Thackersey (SNDT) Women's University, Mumbai
M.pharmacy (pharmaceutics)
2017 — 2019
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