Bharathi Ponnusamy

To seek challenging assignment and responsibility with an opportunity for growth and career advancement as a successfully achievement.

Clinical Research Associate - Manipal hospitals

(2012-03 - 2017-11)

• Developing and writing trial protocols (outlining the purpose and methodology of a trial)
• Presenting trial protocols to a steering committee
• Designing data collection forms, known as case report forms (CRFs)
• Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
• Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• Identifying and assessing the suitability of facilities to be used as the clinical trial site
• Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site
• Liaising with doctors/consultants or investigators on conducting the trial
• Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards

Drug Regulatory Affairs executive - Intermed Pharmaceuticals, GVK Industrial Estate, Porur, Chennai

(2008-09 - 2012-02)

• Preparation, review and submission of technical documents/dossiers (CTD/eCTD) related to Regulatory Affairs for Import/Export of pharmaceutical formulations
• Preparation and review of SOPs
• Compilation of validation protocols/reports
• Preparation, Review, Submission of technical and other documents/dossiers with DCGI/CDSCO/state FDAs for Registration for import of pharmaceutical formulations and bulk drugs
• Import Licenses
• Export Licenses
• Manufacturing & Marketing Licenses
• WHO-GMP Certification
• No Objection Certificates
• Liaising with DCGI/CDSCO/state FDA offices/Directorate General of foreign trade/FICCI/PHD chamber of commerce

M.Tech - Indus Trial Bio-technology - Bharath University, Agaram Road, Selaiyur, Chennai – 600 073 (2008-04)

B. Pharmacy - Vel's College of Pharmacy, Pallavaram, Chennai-600 117. ( The TN Dr.MGR Medical University ) (2005-02)

H.S.C.

• Prince Matric.Hr.Sec.School, Nanganallur, Chennai-600 061 (2000-03)

S.S.L.C(X) - Prince Matric.Hr.Sec.School, Nanganallur, Chennai- 600 061 (1998-04)