Shalini Bose
Senior Associate Scientist Regulatory Writing and Report Submission at Pfizer
- Role
- Senior Associate Scientist at 화이자
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
Experience
Senior Associate Scientist
Nov 2024 — Present · Chennai, IN
Working as a Regulatory writing submission scientist (RWSS) in liase with Drug Safety Research & Development (DSRD) Regulatory Strategy Leads and Medicine Design/PDM colleagues to prepare and support the expert nonclinical sections (pharmacology/ADME/toxicology) of regulatory dossiers and oversee the integration of all nonclinical contributions.As a part of RWSS team I oversee the timelines and reviews associated with the nonclinical summary documents and is responsible for quality review of content for accuracy, correctness, and consistency, and submission-ready formatting, compilation, and compliance of the dossier according to international standards, Pfizer Global Style Rule Book and Style Guide, and PREDICT templates.Performing literature review of nonclinical sections of safety reports which include periodic review of sponsor-initiated studies and literature in the public domain for continuous analysis of relevant nonclinical safety information.
Education
Birla Institute of Technology, Mesra
Master of pharmacy
2019 — 2021
Dr. B. C. Roy College of Pharmacy and Allied Health Sciences 189
Bachelor of Pharmacy - BPharm
2015 — 2019
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.