Talk to sales Try for Free
SAIKAT BHATTACHARJEE

SAIKAT BHATTACHARJEE

Executive @ Norwich Clinical Services

Followers of SAIKAT BHATTACHARJEE658 followers
location of SAIKAT BHATTACHARJEEBengaluru, Karnataka, India

Connect with SAIKAT BHATTACHARJEE to Send Message

Connect

Connect with SAIKAT BHATTACHARJEE to Send Message

Connect

  • Timeline

  • Skills

    Clinical research
    Pharmacovigilance
    Ich gcp
    Pharmacy
    Business development
    Team management
    Market research
    Regulatory affairs
    Sop
    Operations management
    Business strategy
    Microsoft office
    Pharmaceutical industry
    Business planning
    Clinical trials

  • About me

    It's like Forrest Gump said, 'Life is like a box of chocolates.' My career is like a box of chocolates - I never know what I am going to get. But everything I get is going to teach me something along the way and make me the person I am today. That's the exciting part - it's an adventure in itself. Self-believe, passionate to work, keen to learn more, hungry for success, dedication and most important " think different, do different" ...................these all I believe and follow as a principle. Specialties: Clinical research, Pharmacovigilance,Pharmacy

  • Education

    • WBUHS

      2005 - 2009
      Bachelor's degree Pharmaceutical Sciences

  • Experience

    • First Job

      Feb 2011 - Apr 2014
      Executive @ Norwich Clinical Services

    • Quintiles

      Apr 2014 - Dec 2018
      Operations Specialist

      RESPONSIBILITIES Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of secondary review. Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting. Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data. Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements. Mentoring less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.. Show less

    • GSK

      Dec 2018 - now

      Promoted to next grade Promoted to next grade.

      • Senior system configuration specialist-I (Configuration Manager)

        May 2023 - now

      • Senior System technical Specialist II Configuration

        Apr 2021 - Apr 2023

      • Technical System Specialist

        Dec 2018 - Mar 2021

  • Licenses & Certifications