Medical Quality Control
Resume:
Vikram Jagannathan M.D.
Whitehouse Station, NJ 08889
Ph: 908-***-****
E-mail: ******.***********@*****.***
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Summary
Drug safety physician with global pharmacovigilance experience: clinical knowledge of medical diagnosis/treatment; demonstrated knowledge of relevant regulations, guidelines; will make a substantial contribution to case management and pharmacovigilance activities.
Lead Specialist - Case Medical Evaluator (Jun 2008 – present) contract
Global Pharmacovigilance and Epidemiology
Sanofi-Aventis Pharmaceuticals, Bridgewater, New Jersey
Manage case evaluation for assigned products in development as well as marketed products, support signal detection and participate in global pharmacovigilance activities:
o Perform review of adverse event reports for regulatory / clinical assessment as appropriate to maintain compliance with regulations / improve medical quality of cases.
o Interact and work with Case Data Managers for the appropriateness of MedDRA coding and events ranking to minimize reconciliation/data cleaning.
o Assess seriousness, causality and listedness/expectedness of events, ensure accuracy,
completeness and case priority of reports with appropriate company comments for timely distribution and expedited reporting.
o Follow-up needs: determine and direct follow-up queries with relevant information for case completion to minimize redundancy in communication.
o Liaise with Clinical Research Units/Clinical Safety Associates in reconciliation of safety data issues and analysis of safety data in generating ASRs/PSURs.
o Contribute to risk/benefit evaluation: medical interpretation of safety data / prompt identification/communication of potential alert reports and safety signals.
o Coordinate activities with Global Safety Officers and Pharmacovigilance Regulatory Compliance Unit in resolving issues with case evaluation to ensure ICSR quality control.
Therapeutic area: Oncology, Internal medicine PV Database: AWARE
Early Regulatory Assessor- Global Pharmacovigilance (April - June 2008) contract
Sanofi-Aventis Pharmaceuticals, Bridgewater, New Jersey
o Perform early triaging on cases to identify all qualifying regulatory reports
o Identify time deviations to internal procedures on receipt to GPE
o Address immediate reminders and late investigation requests
o Identify cases which meet expedited criteria; determine distribution due date for reportable cases
o Perform Quality control on Individual Case Safety Reports
o Review case safety reports: Notification of significant corrections; Identify compliance issues and investigate root cause of delay PV Database: ClinTrace
Drug and Device Safety Specialist - (July-Dec.2007)
Ferring Pharmaceuticals, Parsippany, New Jersey
o Postmarketing Surveillance and Pharmacovigilance of Drugs and Devices
o Involved in the collection, monitoring, and processing of Adverse Events from healthcare professionals and consumers
o Synthesis of concise medical case narratives
o Created and edited MedWatch forms
o Submission of serious and non-serious adverse events to global pharmacovigilance department and FDA
o Analysis and Interpretation of CIOMS forms
o Involved in the investigation of consumer complaints
o Maintained a database for adverse events, consumer drug complaints, and device complaints
Therapeutic area: Women’s Health and Internal medicine
Medical Information Specialist- (Dec.-2006- Mar 2007) contract
Dendrite Pharmaceuticals, NJ
o Provide Medical and Scientific information to healthcare providers related to specific Intranasal Steroids and Antifungal Preparations
o Discuss and disseminate relevant product information such as drug action, efficacy and adverse effects pertaining to doctors’ clinical experience
o Responsible for managing a physician database and call center activities
o Addressed technical queries raised by doctors either through discussions and/ or referring them to appropriate pharmaceutical literature.
Clinical Experience
Worked as a Physician in the Emergency Room; SRMC & RI Chennai, India (Mar- Jun 2007)
Psychiatry Extern Long Island Jewish Hospital Glen Oaks, NY (May-Dec.2006)
Tsunami Relief Efforts Physician, Tamil Nadu, India (Feb. - May 2005)
Observership in Pathology University of Cincinnati, OH (Oct.-Dec. 2005)
Outpatient and Inpatient Physician SRMC & RI; Chennai, India (July- Sept 2004)
Family Medicine Extern: Hunterdon Medical Center Flemington, NJ (Feb.-June 2003)
Clinical Rotation in Pediatrics Detroit Medical Center Detroit, MI (April 2002)
Clinical Rotation in Internal Medicine Detroit Medical Center Detroit, MI (March 2002)
Clinical Rotation in Internal Medicine Henry Ford Health System Detroit, MI (Feb. 2002)
Externship in Internal Medicine and Cardiology Peninsula General Hospital, Salisbury, MD (May 1998)
Externship in Gastroenterology Bayonne Hospital Bayonne, NJ (May 1997)
Externship in Hepatology at Newark Hospital UMDNJ Newark, NJ (June 1997)
Education
Bachelor of Medicine& Bachelor of Surgery (MBBS): 1995-2003
Sri Ramachandra Medical College & Research Institute, Chennai, Tamil Nadu, India
Affiliated with Harvard Medical School
Louisiana State University 1995
Baton Rouge, LA
Rutgers Preparatory School 1990-1994
Somerset, NJ
Certifications
ECFMG Certified (Educational Commission for Foreign Medical Graduates) May 2005
ACLS Certified (Advanced Cardiac Life Support) March 2006
Basic Life Support and Neonatal Resuscitation Program July 2005
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