Rohit Basuthkar

About Rohit Basuthkar

I am a Pharmacovigilance Physician with hands-on experience in evaluating drug-related…

Experience

1. Senior Safety Physician

   Syneos Health Clinical Solutions

   Mar 2015 — Present · Hyderabad, IN

   Medical review of adverse events reported to investigational and marketed products includingidentification of event/s, confirmation of seriousness, ensure that events are coded and mappedto the appropriate terms in MedDRA, provide assessment of expectedness per reference safetyinformation, assessment of causality, review of narrative for chronology and medical content andprovide medical evaluation comment.Ensure regulatory compliance with respect to the evaluation, reporting and surveillance ofsafety information. Identify, communicate, and effectively manage potential safety issues.Provide medical safety analysis and interpretation for periodic safety aggregate reports (e.g.DSUR, PSUR/PBRER)- Interact with clients\' safety/medical personnel as appropriate to ensure above.Serve as a mentor for other internal safety staff including case processing staff.As a Medical Data Reviewer / Data consistency- Serve as a Subject level Data reviewer (SLDR) and Identify any anomalies in patient reporteddata by performing Subject Level Data Review that require further investigation with the clinicalsite to determine overall accuracy- Review investigation product dosing records to determine adherence to protocol and identifypossible inaccurate / missed dosages. Review all reported Adverse Events (AEs) to ensure all supporting information is expectedand/or implausible data is verified. Review all reported Concomitant Medications to ensure nomedication is disallowed per protocol, supports an existing reported medical condition or isprescribed for a reported AE.Review all inclusion and exclusion criteria to ensure each patient meets minimum level ofacceptance into the clinical trial- Ensure proper end-of-study (EOS) information is correctly documented to determine primaryreason for the patient ending participation in the clinical trial.

Education

• Kamineni Institute of Medical Sciences

  Bachelor of Medicine, Bachelor of Surgery (MBBS), Medicine

  2006 — 2011

Skills

• Healthcare Management
• Oncology
• Informatics
• Clinical Trials
• Surgery
• Public Health
• Medicine
• Patient Safety
• Healthcare
• Healthcare Information Technology
• Hospitals
• Medical Devices
• Clinical Research
• Pediatrics
• Medical Education