Anup Choudhury

Background

About Anup Choudhury

Clinical development #medical director #Medical safety leader #clinical trial and #drug safety #pharmacovigilance #Clinical pharmacologist A dynamic medical professional: MBBS, MD clinical pharmacology and MBA (healthcare services), total 19 years of work experience (9 years in Pharma industry, and 10 years clinical practice) Areas of expertise: 3½ years in global clinical development and 5½ years in global drug safety and pharmacovigilance. Specific strength or experiences: clinical trial protocol development, medical monitoring, benefit-risk evaluation, heath authority interactions, briefing book/dossiers preparation for FDA Advisory Committee and EMA, PRAC assessment reports e.g. article 31 referrals, preparation of submission package; clinical overviews (CO), clinical expert statement, summery of clinical efficacy and clinical safety (type 2 variation SPC update ), clinical study reports (CSR), scientific abstracts, presentations, and manuscripts for journals. Company Core Data Sheet (CDS) and Investigator Brochure (IB) updates, periodic safety reports (PBRER, PSUR, DSUR), Development Safety Profiling Plans (DSPP) and Risk management plans (RMP), signal detection and evaluation, literature reviews etc. Proven ability to work under global teams in matrix environment for complex decision making, project management, networking and leadership skills to lead cross functional teams, ability to work under pressure situations to achieve target/timeline