Khushbu Patel
Drug Safety Specialist
- Role
- Drug Safety Specialist at Merck
- Location
- Franklin, MA, US
- LinkedIn followers
- 500 followers
About Khushbu Patel
Experienced Drug Safety Specialist with 5 years in the pharmaceutical industry, specializing in Pharmacovigilance. Skilled in reviewing adverse events (AEs), assigning appropriate coding, and verifying case seriousness using MedDRA and WHO-Drug dictionaries. Proficient in ICSR case assessment, and signal management. Experienced in reviewing clinical trial protocols and supporting global clinical development. Expertise in safety databases (ARGUS, ARISg,) and comprehensive knowledge of FDA, ICH, and EMA regulations. Proven track record of mentoring and training staff for optimal compliance and performance.
Experience
Drug Safety Specialist
Jan 2023 — Present · Rahway, NJ, US
Performed filing of Product Quality Complaints (PQCs) related to adverse events and ensured data accuracy. Conducted case book-in and data entry, assessed case reports for validation, seriousness, causality, and expectedness. Prioritized adverse event processing based on ICH dates and completed case processing tasks including safety data entry, coding, and quality review. Provided clinical safety support for FDA communications and collaborated on data cleaning requirements at the site level.
Education
Grand Canyon University
Health sciences
Massachusetts College of Pharmacy and Health Sciences
Bachelor's degree, Pharmaceutical Sciences
2020 — 2023
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.