Anupam Rajesh
Safety Scientist | Subject Matter Expert | Signal Management | Medical Writer
- Role
- Safety Scientist (Manager) at ICON plc
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Anupam Rajesh
Experienced Regulatory, Pharmacovigilance, and Laboratory Systems Specialist with 15…
Experience
Safety Scientist (Manager)
Aug 2021 — Present · IN
To prepare an aggregate report plan and aggregate reports (PBRER, DSURs, PADER/PAER, Local Annual Report, ACO) as per regulatory standards and sponsor standard operating procedures.• Author and/or review the Pharmacovigilance System Master File (PSMF) updates, quarterly updates and new PSMF preparation for EU submission.• Perform signal detection for assigned products using ICON methodologies [e.g. signal management tool (Signet, and Orbit), literature review (DistillerSR), individual case review), to detect safety signals for assigned products• Prepare and maintain high-quality signal detection documentation (e.g, Safety surveillance planning documents, Signal Detection Report, Signal Assessment Report, Signal Evaluation Report and Ad hoc reports, if needed).• To provide support for the preparation, implementation and review of ad hoc safety documents such as Risk Management Plans (RMPs), Safety Summaries, and Health Authority (HA) responses.• Contribute to the ongoing enhancement of PV processes and safety systems, focusing on compliance, efficiency, and quality.• Oversee safety-related product information variations and support labeling updates in line with current safety data and regulations.• To prepare a response for any regulatory authority queries related to assigned post marketing products/clinical trials.• To review all the project specific PVAs and maintain a record as per project requirements ensuring local implementation.• To support pharmacovigilance risk assessments and due diligence activities, as required by sponsor or QPPV.• To provide regional support in Europe/Canada in absence of other Safety Scientist to meet local reporting requirements for Pharmacovigilance and submission of DSUR and other safety documents as necessary.• Literature Search & Review: Authors and supports literature search and review plans, defining search parameters, and conducting aggregate safety analyses using databases like DistillerSR and Pubmed.
Education
INDIAN SCHOOL OF BUSINESS MANAGEMENT AND ADMINISTRATION
Master's degree
2022 — 2024
Kirti College
Bachelor's degree
2005 — 2008
ICFAI University
Master of Business Administration (M.B.A.)
2017 — 2020
CREMA
Advance Post-graduate Diploma
2008 — 2009
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