Summary
Work History
Education
Skills
Registrations
Languages
Training
References
Timeline
Generic
Dr. Saravanan Shanmugasundaram

Dr. Saravanan Shanmugasundaram

Chennai

Summary

Motivated professional with a passion for tackling new challenges. Demonstrates a strong work ethic, adaptability, and exceptional interpersonal skills. Proven ability to excel in independent work settings and rapidly acquire new skills.

Work History

Safety risk lead

Pfizer healthcare India Pvt Ltd
Chennai
- Current
  • Continuous monitoring and evaluation of safety data and risk assessment for marketed and developmental products
  • Conduct Risk Management Committee meetings
  • Develop strategy for safety queries from Health Authorities, Pharmacovigilance and Risk Minimization Plans
  • Communicate product safety profile in Investigator’s Brochures, Core Data Sheets, Product labeling, Regulatory Safety reports
  • Development of best practices for safety surveillance, signal detection and management, risk management, benefit/risk assessment, and safety & risk communication
  • Product safety and risk assessment during due diligence activities
  • Co-chair Product Benefit Risk Committee.

Drug Safety Physician/Medical Reviewer

Accenture Services Pvt. Ltd.
Chennai
  • Perform single case medical assessment including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions
  • Provide medical advice and insights to therapeutic area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports
  • Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed
  • Worked as Drug safety physician for the client Pfizer and currently working for the client Teva pharmaceuticals as Drug safety physician.

Investigator

Lotus Labs
Chennai
  • In charge of all clinical and medical aspects of the studies being conducted by the laboratory; personally conducted and/or supervised the studies
  • Delegated personnel for study related activities after confirming that they had adequate training and were qualified to perform their tasks
  • Ensured that Ethics Committee (EC) approval was obtained for the study and issues/questions raised by the EC were clarified
  • Permitted monitoring and auditing by sponsor and inspection by regulatory authorities
  • Ensured that the protocols for study were scientifically sound and gave a clear detailed description of trial activities
  • Provided timely inputs on the protocols (for example: dosing information, contraindications, warnings, precautions, adverse events, drug interactions) to Protocol writing group
  • Read and understood the Investigators Brochure or appropriate information on the drug prior to the start of the study
  • Complied with all applicable regulations, completed form 1572 and 3455 when applicable
  • Reviewed all Serious Adverse Events reporting forms after they were filled by the designee
  • Ensured that all study reports are accurate and consistent with the source data and authorized the same.

Duty Medical Officer

Aysha Hospital
Chennai
  • Managed patients with acute myocardial infarction, ischemic heart disease, left ventricular failure, arrhythmias; trauma; poisoning, snake bites
  • Scorpion stings; epilepsy and acute severe asthma
  • Managed neurological emergencies
  • Supervised admission of patients in General and Surgical Wards
  • Attended Out Patient Department; clinically evaluated and worked up differential diagnosis and investigations of patients
  • Listed patients for elective surgeries
  • Responsible for post-operative care of admitted patients in surgical department
  • Actively took part in group discussions and case presentations with the hospital physicians and chief.

Duty Medical Officer

Shyamala Nursing Home
Chennai
  • Managing Acute myocardial infarction, Ischemic heart disease, Left ventricular failure, Arrhythmias, etc
  • Managing Neurological Emergencies
  • Managing Trauma patients
  • Managing Epilepsy and Acute Severe Asthma cases
  • Responsible for admission of patients in General
  • Attending Out Patient Department
  • Clinical evaluation and working up differential diagnosis and investigations
  • Actively took part in group discussions
  • Case presentation.

Education

Doctor of Medicine (General Physician) -

Saint Petersburg State Medical Academy named after I. I. Mechnikov
Russia
03.2003

Skills

  • Strategic Thinking
  • Training and coaching
  • Cross-functional team leadership
  • Data-driven decision-making
  • Team Building and Motivation
  • Teamwork and Communication

Registrations

  • Tamil Nadu Medical Council, 80708, 2007
  • Indian Medical Council, 30684, 2007

Languages

  • English, Speak, Read and Write
  • Russian, Speak, Read and Write

Training

  • Workshop on Dr. Mohan’s DSCGP Affiliate in Diabetology Consulting Services, Chennai, 2006
  • Third MDRF-ADA PG course in Diabetology, Chennai, 2006
  • Updates in Diagnosis & Management of Cardiovascular Disorder, Chennai, 2007
  • Training programme for clinical investigators conducted by Lotus Clinical Research Academy Pvt. Ltd., Chennai, 2007
  • Second International Symposia on Advance in Diabetes, Chennai, 2007
  • CAP Laboratory Accreditation program conducted by the College of American Pathologists, Chennai, 2008
  • Advanced Cardiac Life Support training conducted by American Heart Association, Chennai, 2010
  • Basic Life Support training conducted by American Heart Association, Chennai, 2010
  • ICH – Good Clinical Practice training conducted at Lotus Labs Pvt. Ltd., Chennai, 2010
  • Enhancing Personal Performance conducted by Metis ERC (1) Pvt. Ltd., Chennai, 2010
  • Short course on Fundamentals of Clinical Data Management conducted by the Christian Medical College, Vellore, 2011
  • Short course on Fundamentals of Biostatistics, Principles of Epidemiology and SPSS, Vellore, 2011

References

References available upon request.

Timeline

Safety risk lead

Pfizer healthcare India Pvt Ltd
- Current

Drug Safety Physician/Medical Reviewer

Accenture Services Pvt. Ltd.

Investigator

Lotus Labs

Duty Medical Officer

Aysha Hospital

Duty Medical Officer

Shyamala Nursing Home

Doctor of Medicine (General Physician) -

Saint Petersburg State Medical Academy named after I. I. Mechnikov
Dr. Saravanan Shanmugasundaram