Verified recordBiotechnology Research

Anshuman Mudgal

Safety & Pv Coordinator at Syneos Health

Based in Gurgaon, India

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Seniority

Staff

Department

Other

Location

Gurgaon

Industry

Biotechnology Research

Company size

23K

Contact information

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Email

1 credit

a•••••••@syneoshealth.com

Phone

5 credits

+91 ••• •••• ••••

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Background

About Anshuman Mudgal

A Pharmacologist who did his BPharm from PGI, Rohtak & after qualifying GPAT'19(Graduate Pharmacy Aptitude Test, National Testing Agency, All India Council for Technical Education) with an All India Rank of 412, stepped in to pursue MPharm in Pharmacology from Jamia Hamdard, New Delhi.(NIRF ranked #1 University of India for Pharmaceutical Research & Sciences) while being sponsored by AICTE. I have keen knowledge of Pharmacovigilance, ICH Guidelines, GVP Module 6, PSMF writing, E2B R3, 21 CFR Part 11, ICSR Processing, Literature Monitoring, Follow Up of Spontaneous Cases, Aggregate Reports, Signal Detection, Data Entry in Safety Databases(Argus, PvEdge), ASPR, Clinical/Pre-Clinical Trials, Animal Handling. Experienced in- Literature Monitoring: Perform Literature Search, Monitor medical and scientific literature for published articles relevant to the safety profile for assigned product(s), Check for validation of the articles, Extract the full-text articles & abstract from different literature search databases (Pubmed, Google Scholar, Embase)- Book-In: Book-in of all the valid cases in Databases- Triage: Evaluation/Triage- Narrative Writing, Causality assessment, Labeling - ICSR Processing: Evaluation & Triage of valid articles, Data entry of cases received as Literature in the Safety Database(Argus, PvEdge), Carry out MedDRA/WHODD Coding for Event, Medical history, Lab, etc- Follow Up: Follow up of cases- Other Roles & Responsibilities: Team co-ordination, Completion of the assigned work on time with good quality, Preparation & structuring of SOP’s & Working Guidelines- Processing POP(Patient Oriented Programs), Social Media Program, Post Marketing Studies & Health Authority Cases, ASPR(Anonymous Single Patient Report) from MHRA- PSMF (Pharmacovigilance System Master File) preparation. Coming to my hobbies, •National Record Holder(355 Kgs) in Deadlift(Powerlifting) & Official Strongman of India Record Holder. •Youngest Grade 4 Certified Violinist(2013) from Trinity College of Music, London in North India. Well experienced in Studio Sessions & On Stage Performances & Concerts beside renowned musicians and artists performing for about audience strength. Highly Experienced Performer in Numerous Symphonies. •Table Tennis(3xNational Player) •MMA Kickboxing, Tae Kwon Do(2xNational Bronze Medalist) IG: anshuman_mudgal

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