Incumbent will work closely with Sales and Manufacturing Departments, as well.
Prepare reports of PMS studies for regulatory submission. They should have undergone SOP training in Clinical Research along with knowledge in Standard Operating Procedures for clinical research and quality assurance.
Provide pharmacovigilance input on designated products. Coordinates the development of protocol level documents and plans.
Responsible for supporting pre-clinical and clinical development of HCV compounds. Participate in company core data sheets and product label changes and medical interpretation of safety data for regulatory documents.
Monitoring of Adverse Events from clinical trials. To intimate any discrepancy in conduct of trial. Apply results to bug tracking system.
Responsible for supporting pre-clinical and clinical development of HCV compounds.
Participate in company core data sheets and product label changes and medical interpretation of safety data for regulatory documents.
This position will be responsible for production of analysis datasets and specifications, well documented code, summary tables and some statistical analysis of data.
Interprets and prepares virology data for regulatory submissions.
Provide pharmacovigilance input on designated products. To conduct, Monitor clinical studies as per GCP.
They should have undergone SOP training in Clinical Research along with knowledge in Standard Operating Procedures for clinical research and quality assurance. Report Generation; publication. Solids and liquid dosage form experince. The candidate will perform data entry, data clean up, and data loading to maintain and expand a commercially successful database of available chemicals.
Then they are transform into the rice plant for the transgene _expression_ and finally their analysis. Responsible for supporting pre-clinical and clinical development of HCV compounds.