Dr. T. Shobha .

Clinical Pharmacologist-Asia Operations at Ecron Acunova
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Contact Information
us****@****om
(386) 825-5501
Location
Karnataka, India, IN
Languages
  • Kannada -
  • Hindi -
  • Tamil -
  • Telugu -

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Balaji Iyengar

Dr. Shobha is a highly enthusiastic person & works with great intensity. Highly focused in any assignment given to her, she gives her best. She is a great asset to her team. I wish her all the best.

LinkedIn User

It gives me immense pleasure to recommend Dr.T.Shobha. Shobha and I completed medical graduation together. As a student, Shobha's intelligence, diligence and honesty outweighed many other students in the class. During the course of studies, her grades were exceptionally good. Moreover, her ability as a leader to other students and confidence in varieties of challenges had brought her praises from all over. Her interest in pharmacology and clinical medicine led her to complete post graduation in clinical pharmacology. I have strong confidence that Shobha will be a great asset to her employers and wish all the best for her future endeavor.

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Experience

    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical Pharmacologist-Asia Operations
      • Dec 2007 - Present

      •Strategically responsible for expansion of Ecron Acunova's operations in Asia Pacific countries •Responsible for developing Feasibility, Proposal & RFP’s and Client Interaction & follow-up. •Co-ordinate with Regulatory team, Clinical Operations team, Clinical data management team, Medical writing & bio-statistics team, Central Lab & Pharmacovigilance and BABE; Phase I team. •Conduct feasibilities with the Investigators/ Hospitals/ Tertiary care centers •Provide expert opinion to… Show more •Strategically responsible for expansion of Ecron Acunova's operations in Asia Pacific countries •Responsible for developing Feasibility, Proposal & RFP’s and Client Interaction & follow-up. •Co-ordinate with Regulatory team, Clinical Operations team, Clinical data management team, Medical writing & bio-statistics team, Central Lab & Pharmacovigilance and BABE; Phase I team. •Conduct feasibilities with the Investigators/ Hospitals/ Tertiary care centers •Provide expert opinion to team members •Provide scientific guidance & study assumptions to all the proposals. (Phase I to Phase IV & BABE proposals). •Develop CSO (Case study outline), to build the proposal. •Guide team to build RFI’s. •Develop White Papers to the clients; and motivate clients to conduct clinical trials in India and preferably with our CRO. •Develop epidemiological reports. •Provide scientific inputs, expertise opinion and technical rationale to other teams & Clients with regards to Clinical trials and Marketing. •Pharmacovigilance: SAE narratives, generating annual safety reports, CIOMS •Central lab:Responsible for Central lab business and Projects Show less •Strategically responsible for expansion of Ecron Acunova's operations in Asia Pacific countries •Responsible for developing Feasibility, Proposal & RFP’s and Client Interaction & follow-up. •Co-ordinate with Regulatory team, Clinical Operations team, Clinical data management team, Medical writing & bio-statistics team, Central Lab & Pharmacovigilance and BABE; Phase I team. •Conduct feasibilities with the Investigators/ Hospitals/ Tertiary care centers •Provide expert opinion to… Show more •Strategically responsible for expansion of Ecron Acunova's operations in Asia Pacific countries •Responsible for developing Feasibility, Proposal & RFP’s and Client Interaction & follow-up. •Co-ordinate with Regulatory team, Clinical Operations team, Clinical data management team, Medical writing & bio-statistics team, Central Lab & Pharmacovigilance and BABE; Phase I team. •Conduct feasibilities with the Investigators/ Hospitals/ Tertiary care centers •Provide expert opinion to team members •Provide scientific guidance & study assumptions to all the proposals. (Phase I to Phase IV & BABE proposals). •Develop CSO (Case study outline), to build the proposal. •Guide team to build RFI’s. •Develop White Papers to the clients; and motivate clients to conduct clinical trials in India and preferably with our CRO. •Develop epidemiological reports. •Provide scientific inputs, expertise opinion and technical rationale to other teams & Clients with regards to Clinical trials and Marketing. •Pharmacovigilance: SAE narratives, generating annual safety reports, CIOMS •Central lab:Responsible for Central lab business and Projects Show less

    • Germany
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Clinical Research Physician
      • Nov 2007 - Apr 2010

      • Responsible for screening and enrolling healthy human volunteers for various bio-studies. • Involved in various process of conduct of BABE study, Safety reporting, adverse event monitoring, up keeping volunteer and subject wellbeing. • Deputed by Principal investigator to manage trial critical decision in study compliance, phlebotomy and other operational aspects of trial. • Involved in conduct of 45 studies which includes BABE & Phase I & Drug- drug Interaction studies. • Responsible for screening and enrolling healthy human volunteers for various bio-studies. • Involved in various process of conduct of BABE study, Safety reporting, adverse event monitoring, up keeping volunteer and subject wellbeing. • Deputed by Principal investigator to manage trial critical decision in study compliance, phlebotomy and other operational aspects of trial. • Involved in conduct of 45 studies which includes BABE & Phase I & Drug- drug Interaction studies.

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Junior Resident
      • Mar 2006 - Dec 2006

      • Performed emergency medical and surgical as well as routine patient care services • Undertook training of dealing with various aspects of patient care and emergency dealing in hospital setting in all the departments. • Performed many invasive and non-invasive procedures at Emergency ward, Outpatient as well as in-patient admission-including ITU & ICU. (IV lines, Central lines, Ascitic tap, Bone marrow aspiration and biopsy, CPR, Endotracheal intubation, Tracheostomy etc...) • Performed emergency medical and surgical as well as routine patient care services • Undertook training of dealing with various aspects of patient care and emergency dealing in hospital setting in all the departments. • Performed many invasive and non-invasive procedures at Emergency ward, Outpatient as well as in-patient admission-including ITU & ICU. (IV lines, Central lines, Ascitic tap, Bone marrow aspiration and biopsy, CPR, Endotracheal intubation, Tracheostomy etc...)

Education

  • Manipal Academy of Higher Education
    MD, Pharmacology
    2007 - 2010
  • Rajiv Gandhi University of Health Sciences
    MBBS, Medicine & Surgery
    2000 - 2005

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