PK Scientist - Clinical Pharmacokinetics
PK Scientist - Clinical Pharmacokinetics
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Job Description
- Preparation of Synopsis All geographies
(i) Prepare synopsis for the preparation of protocols for BE study
(ii) Review and submission of the BENOC protocols for DCGI submission
(iii) To provide CPK inputs for preapex products
- Preparation and Review of Biostudy reports for specified markets
- Review the summary of pilot BE studies report towards the submission to regulatory affairs
- Review of report wrt clinical domain eCTD review and submission to RA as per the required timeliness
- Leverage gap assessment
3. Investigational product handling
To coordinate and arrange for the IPs from the PDTs and ensure shipments to respective CROs for the conduction of pilot and pivotal BE studies IN ORDER TO Ensure the availability of IPs before the initiation of the BE study
- BE results compilation for allocated projects
i)Preparation of statistical analysis of the pilot and pivotal BE studies.
- Coordination with CROs
To coordinate with the CROs/vendors for BE study follow up progress and .
Qualifications :
Postgraduation in Pharmacy
Additional Information :
Clinical Pharmacokinetics Clinical research GCP/GLP BA/BE
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
