AMIT ***** , MD

EDUCATION VANDERBILT UNIVERSITY Nashville, TN
***** ***** ***** OF MANAGEMENT (MBA 2013)
Concentrations: Healthcare, General Management and Strategy.
• ***** Merit Scholarship.
• Summer Project Leader for Perioperative process improvement initiatives at Vanderbilt Children’s Hospital.
• Led a Nuclear radio-pharmacy integration project with Hospital Corporation of America.
• Conducted market research for new product planning at Insight Genetics Inc.
• YourEncore Oncology Prediction Market Expert.
• One of the 12 students enrolled in self-guided Leadership Development Program at ***** .
• ***** Admissions Ambassador.

UNIVERSITY OF DELHI New Delhi, INDIA
Major: Nuclear medicine (a subspecialty of Radiology), *****
• Published case report in Indian Journal of Nuclear medicine (Sep 2006) and conducted information sessions for fellow residents in different hospitals highlighting optimal utilization of the non-invasive functional imaging procedures.

UNIVERSITY OF DELHI New Delhi, INDIA
M. B. B. S. , Dec 2004 (Equivalent to MD in US)
• Area booth supervisor for W. H. O. sponsored National Pulse Polio Immunization Project.

EXPERIENCE NOVARTIS HEALTHCARE PVT. LTD Hyderabad, INDIA
***** Pharmacovigilance Expert (Drug Safety Physician), Drug Safety & Epidemiology (DS&E)
• Analyzed, interpreted and evaluated safety data (Argus and Empirica), for important post marketed products, two new developmental projects and completed complex data review for an yearly PSUR of a $ 579 million metabolic drug involving more than 7000 patient case reports, and submitted the quality reports on all occasions without a timeline extension.
• Coordinated activities of Safety Management Teams, and provided safety inputs on Risk Management Plan (RMP) and Core Data Sheet (CDS) revisions, Clinical Expert Statements, Annual Safety Reports and Pharmacovigilance licensing agreement development.
• Prepared European Union SUSAR listings & Investigator Notifications for Clinical trial projects.
• Influenced marketing team to integrate relevant safety data collection in the patient support programs.
• Led global cross functional project teams of 8-10 colleagues, created communication channels that did not exist previously to improve the efficiency of remotely located teams and to promote sharing of best practices and knowledge.
• Presented changes in workflow including therapeutic area alignment for safety processing teams, quality checklists for follow-ups, and real life example sharing which led to 10% increase in productivity due to reduction in re-work and due to strengthened product knowledge.

***** Clinical Safety Scientist (CSS) Oncology, DS&E
• Managed Argus workflow and people resources, and developed user friendly product guidance documents for consistent data processing specific to products which eliminated bottle necks and reduced errors.
• Mentored nearly 6 new colleagues each year on pharmacovigilance procedures after their class room training, provided hands on training, shared best practices, supported their rapid onboarding and achieved their full productivity in less than the allocated time.
• Monitored system related issues during version changes for Argus affecting user productivity and provided possible solutions to system experts for further discussions with external vendors to help prevent future problems.
• Worked on PSURs, US PADERs, MedDRA coding, Quality Control and labeling assessment of single case reports.

***** Safety Processing Expert, DS&E
• Represented DS&E in Novartis office relocation (Green building) project, worked with information security officers to lay out specifications for the archive room in DS&E and delivered within the specified timelines.
• Restructured training plan to a practical and comprehensive rotational program for interns and acted as a subject matter expert for new hires.
• Supported the organization during UK health authority (MHRA) inspection by reviewing line listings for data accuracy for various products.

ADDITIONAL • “Above & Beyond” Award for supporting MHRA inspection and for reviewing 3000 case reports in Feb 2009 and for actively supporting the therapeutic area during difficult situations in Dec 2010.
• International Diploma in Clinical Research, Clinical Trial Monitoring and Good Clinical Practices (GCP), Kriger Research Group, Canada (online).
• Interested in meeting people, community participation, social networking on facebook and linked in, attending social and cultural events, playing softball and racquet ball, writing poems and reviews on personal blog.