Ravindra Yadav
Pharmacovigilance associate|| Signal detection and management ll DSUR|| PEBRER|| PSUR|| SUSAR|| ARGUS|| Ex Syneos health ll BBAU Central university ll M. pharma pharmacology|| Bristol myres squibb
- Role
- Pharmacovigilance Associate Signal Detection and Management at Bristol Myers Squibb
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Ravindra Yadav
I have hands-on expertise in end-to-end case processing in pharmacovigilance databaseArgus.I have experience of MedDRA event coding, product coding of PMS and SP cases. Experience of Narrative writting of PMS, SP and regulatory authority cases Experience of assessing causality of event and expectedness. My therapeutic area experiences include Osteoporosis, Type 1, 2 diabetes and cancer. Assessed labeling of non- serious adverse events originating from spontaneous, clinicalsources with reference to CORE, USPI, IB periodic, SP Requested and provided follow-ups on adverse events by preparing, sending InfoPathand HCP letters. Managed individual Case Safety Reports of non -serious cases from spontaneous andsolicited programs, literature and E2B cases, which included.
Experience
Pharmacovigilance Associate Signal Detection and Management
Mar 2025 — Present · Hyderabad, IN
Key Role – As a Pharmacovigilance Associate Successfully identified and initiated new safety signals in Cosmos, ensuring proactive monitoring, structured evaluation, and timely progression to risk assessment stages.Streamlined extraction and reconciliation of global sales data for PBRER and DSUR reports, supporting accurate exposure calculations and regulatory compliance. Developed comprehensive standard safety data packages integrating Proteus and Solstice outputs, enabling informed risk mitigation and benefit-risk evaluation. Contributed to end-to-end preparation of PBRER and DSUR aggregate reports, ensuring high-quality documentation aligned with regulatory timelines. Effectively managed Health Authority queries as an SME, delivering precise data verification and resolution within stipulated deadlines.Coordinated SMT updates and facilitated SMT and SDRM meetings, driving structured safety discussions through well-documented minutes and asset-specific memos. Generated validated line listings and ensured accurate upload into CARA to support aggregate safety reporting and submission readiness
Education
Mahura Bal Vikas High School and Junior College Nallasopara (E) Mumbai
High school
Baba saheb bhimrao ambedkar university lucknow
m.pharma, Pharmacology and Toxicology
2020 — 2022
Dr. A.P.J. Abdul Kalam Technical University
Bachelor of Pharmacy - BPharm, Pharmacy
Babasaheb Bhimrao Ambedkar university ( A central university) vidya vihar Raebareli road lucknow
M. Pharma (pharmacology), Oncology and Cancer Biology
Vidya Varidhi Vidyalaya and junior college Nallasopara (E) Mumbai
Intermediate
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