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Pharmaceutical Physician (Medical post graduate in Pharmacology), have 9 years of clinical research and 2 years of General Medical Practice experience. Experienced in therapeutic areas mainly Oncology (hematological and solid tumors), Endocrinology (type 2 DM), Gastroenterology, Nephrology, Rheumatology and Infectious disease. Experienced in Biosimilar clinical development, product launch and post marketing studies. Experienced in Medical review of large data sets, line listings, eCRF from clinical trials and different periodic safety reports preparation.


Current Experience

  • Senior Manager - Drug Safety & Risk Management
    Since March 2015

Past Experience

  • Sr. Clinical Research Physician
    September 2011 --- February 2015
    • Heading the team of Clinical research physicians in India. Coaching and Mentoring, resource allocation and oversight of allocated projects to the team • Preparation and attending bid defense meetings, input for proposals and support to BD • Member of global 24/7 medical coverage, providing medical consultation for global studies • Working with Centralized monitoring dept. to develop review metrics and suggest interventions needed by use of recent IT systems. • Medical monitoring for assigned projects Leader for Medical Review Unit within ICON Clinical Research – • Project management for medical data review projects (Regional or Global Clinical trials) • Medical review of clinical trial data, Medical query generation and final approval for query closure • Generation and review of client specific periodic Safety Monitoring reports (SMRs) with emphasis on unidentified safety issues • Medical data review of large data sets, medical data cleaning, review of CSRs

  • Medical Monitor, Clinical Development of Biosimilar
    August 2010 --- August 2011
    •Clinical Development of Biosimilars, Medical Monitoring of clinical trials, Medical review of Post Marketing Surveillance case reports, review of Periodic Safety Update Reports, Post Marketing Surveillance study protocols. • Medical input for product launch, preparation of training slides and resolution of doctor’s queries. •Training of sales team during product launch

  • Medical Monitor
    June 2008 --- April 2010
    • Preparation of training presentation and to provide therapeutic area, protocol and safety reporting training to study team • Assist project team during Site Qualification Visits and Site Initiation Visits • Continuous Medical Monitoring of trials including eligibility assessment, review of lab reports, assessment of protocol deviations and regular follow up of enrolled patients • Resolution of medical and safety related queries from sites and project team • Participation in 24/7 medical cover service • Preparation of Safety Monitoring Plan in accordance with applicable Standard Operating Procedures (SOPs), Good Clinical Practice and local or applicable international regulations • Training of the project team about clinical safety related procedures/regulatory obligations • Review of serious adverse event reports for completeness, assessment of expectedness and discussion with study investigators regarding causality assessment and other issues, reporting to regulatory agencies and sponsor • Preparation and review of case narratives for SAEs and SUSARs and forward them to clients • Review of lab reports to identify the safety signals and notify to them to the Sponsor on regular basis

  • Clinical Investigator
    January 2006 --- January 2008
    TEVA group of company. Clinical Investigator for PK studies


LinkedIn Assessment :
oncology clinical trialsmedical monitoringMedical ReviewPharmacovigilanceprotocol developmentbiosimilarBiologicsNCE trialPharmacovigilanceProtocolClinical trialsGCPoncologymedical monitoringMedical ReviewBiologicsClinical researchClinical DevelopmentICH-GCPCROClinical Study DesignMedical writingpharmacologySOPClinical monitoringSOPTherapeutic Areas


  • MD in Clinical Pharmacology from Gajra Raja Medical College, Gwalior in 2006
  • MBBS in Medicine from Netaji Subhash Chandra Bose Medical Colloege, Jabalpur in 2002

Training and Certification

  • Diabetes - a Global Challenge Certification
  • HSPH-HMS21x, Fundamentals of Clinical Trials Certification
  • Vaccine Trials: Methods and Best Practices Certification


BrightOwl Assessment:
Self Assessment:
Full Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Medical Director
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position
  • International:

Area / Region

Mumbai, Maharashtra, India


Driving License
  • No