Julee Sinha
PV Scientist, Signal management, surveillance, Benefit risk assessment, Aggregate Reports (PBRER, PADER, ACO), ICSRs-Patient safety at Fortrea India
- Role
- Pv Scientist at Fortrea
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Julee Sinha
Dentist (BDS) by training- Approx. 14 years total experience and experience in patient safety (pharmacovigilance) and more than 9 years in aggregate safety reporting/ regulatory report writing and signal management- Currently working as Pharmacovigilance scientist (Authoring and review of signal detection and evaluation reports, signal management, watchlist development and patient safety surveillance for medicines and vaccines), Health Authority/ regulatory response and preparation of benefit risk assessment report, label update, experience of authoring, reviewing and expert review of periodic aggregate safety reports (PBRER, PADERs, ACO, CO, addendums), also planning of PBRERs, PADERs, ACOs, DSURs and SASRs as per regulatory requirement (EMA, FDA or local), RMP update, Literature review, training and leading team of more than 20 staffs, ICSRs (all types including literature)-Experienced as Line manager -Good knowledge of the PV Industry -Strong interpersonal skills to interact with clients, management and peers effectively -Experience in customer handling and relationship -Ability to perform task management, people management
Experience
Pv Scientist
Sep 2024 — Present · Bengaluru, IN
Involved in Signal management (detection, validation, prioritization, assessment, risk classification, and label update recommendation) of antibiotics, antivenoms and vaccines, expert review of regulatory reports (PBRERs, and PADER) for vaccines and RMP update, safety section of clinical overview, watchlist development. Authoring of signal detection (SD) report, signal evaluation report (SER) and PV assessment reports.
Education
Kendriya Vidyalaya, Patna
10+2
2000 — 2002
Manipal College of Dental Sciences
Bachelor of dental surgery
2006 — 2011
DAV public school, Patna
10th
2000
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.