Experience

Accenture

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Medical Writer

  • Jan 2018 - Present

  ➢ Drafting of all narratives (AE’s, OSME, AED, SAE's) for clinical study reports. ➢ Preparation and review of clinical documents and safety reports (e.g. CSR, Bridging report, Clinical CTD modules, IB, SUSASAR). ➢ Create all documents in accordance to all applicable standard operating procedure. ➢ Assisting for aggregate reports ➢ Plan, organize, and manage daily work to meet service level timelines and deliverables. ➢ Work with the medical writing team lead to escalate issues or tasks outside the normal scope of work. Show less



Lotus Labs Pvt Ltd

• India
• Research Services
• 100 - 200 Employee

• Senior Quality Assurance Analyst

  • Jul 2015 - Jan 2018

   Compliance of study related activities to good clinical practice, concerned standard operating procedure and protocol.  Reporting to Senior Executive for all activities related to the projects.  Maintain inventory of log books.  Maintain obsolete Clinical and Medical diagnostic service standard operating procedures and working documents relating to the same departments.  Conducting facility and quality system audits.  Check for compliance of study related activities to good clinical practice, concerned standard operating procedures and protocol.  Inspection of the log books as a part of the system audit.  Monitoring archival of the documents.  Review of clinical raw data for internal consistency.  Sign a statement declaring that the study has been conducted according to good clinical practice / concerned standard operating procedures, wherever appropriate.  Preparation of standard operating procedures related to the Clinical Quality Assurance department.  Checking the display copies of standard operating procedure to ensure that they are the current versions.  Retrieval of documents from the archives as and when required.  Issue of forms, case report forms and log books to the Clinical department.  Review of documents and ensure compliance with respect to the validation and calibration of clinical instruments and software as per standard operating procedure and validation master plan.  To carry out other responsibilities as and when assigned by the management.  Responsible for monitoring the conduct of BA/BE studies.  Conducted internal audits.  Familiar with protocol and amendment review, raw data review (clinical), Clinical study and Clinical Summary updates, Clinical study reports.  Familiar with STDM tables and analyses of CDSIC package.  Ensures Serious Adverse Event (SAE) reporting according to project specifications.  Ensure the subject safety throughout the study Show less



Micro Therapeutic Research Labs Private Limited

• India
• Research Services
• 100 - 200 Employee

• Ra-qa

  • May 2014 - Jun 2015

  research associate- Quality Assurance research associate- Quality Assurance



Semler Research Center

• Salem, Tamil Nadu, India

• Clinical Research Associate

  • Dec 2011 - Apr 2014