Yogesh Badhan
Leadership| Drug Safety| PBRER, DSUR, ACO| Signal detection| Pharmacovigilance| Risk management (RMP)| Clinical research| Artificial intelligence
- Role
- Associate Director (Team Lead) Aggregate Report and Risk Management at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Yogesh Badhan
Thank you for profile visit.A competent professional currently working with Novartis Healthcare as Subject Matter Expert (Medical Safety Writer) in aggregate reports (PBRER, DSUR, RMP, Signal detection). Previously worked as Senior Pharmacovigilance Scientist in aggregate reporting team. Involved in preparation of Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Management Plan (RMP), Periodic Safety Update Reports (PSURs), Addendum to clinical overview (ACO), PADERs and PSUR Addendum Reports (ARs). Hands-on experience of Signal detection, CSR, ARGUS, Aware and Arisg databases.
Experience
Associate Director (Team Lead) Aggregate Report and Risk Management
Jul 2024 — Present · Hyderabad, IN
Currently involved in techno-functional role of handling team of expert Aggregate reports and Risk management writers. Also contributing as Subject Matter Expert to core technical domain.
Education
National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali
Master in Clinical Research
2011 — 2013
Mahatma Gandhi Vidyamandir Pharmacy College, Panchavati
Bachelor of Pharmacy (B.Pharm.)
2008 — 2011
Skills
- Gcp
- Icmr Guidelines
- Hplc
- Pharmacovigilance
- Pharmacokinetics
- Medical Writing
- Biostatistics
- Protocol Design
- Crf Design
- Pharmacology
- Clinical Research
- Clinical Trials
- Icf
- Protocol Designing
- Business Analysis
- Case Report Forms
- Pharmaceutical Research
- Ich-Gcp
- Spss
- Drug Delivery
- Sop Development
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.