AYUSH Clinical Research Associate

11/Aug/2014

Eligibility: BAMS/BHMS.

Location: Goa

Job Description

  1. Bioequivalence project planning & submission to USFDA, EMA, Brazil & rest of the world countries.
  2. Comprehensive knowledge of BA/BE guidelines (both clinical and bioanalytical) of USFDA, EMA, Brazil, TGA, Canada etc.
  3. Clinical and Bioanalytical in process audit of CROs.
  4. Coordination with CRO for proper conduction of Bioequivalence studies.
  5. Reviewing the Protocol, CRFs, ICFs, Clinical Reports, Bioanalytical method validation report, BA reports, chromatograms and other trial related documents.
  6. Ensuring compliance to all regulatory requirements regarding conduct of BA/ BE study for generic drugs filing.
  7. Comprehensive knowledge of schedule Y, CDSCO guidelines and Drugs & Cosmetics Act mainly related to applications for various licenses and BE NOC.
  8. Serve as a mentor to junior level PK scientists.
 
Interested candidates can mail their CV at info@physislearningacademy.com

Details Not Disclosed

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