Interprets and prepares virology data for regulatory submissions.
A HO licence is preferred.
Ensure regulatory compliance in respect of pharmacovigilance. Degree: Life science degree expected with particular focus on virology. Construct use is of two types, one for the overexpression and other for the RNAi.
Degree: Life science degree expected with particular focus on virology.
Construct use is of two types, one for the overexpression and other for the RNAi.
Ensure that the global pharmacovigilance database is updated periodically.
Report Generation; publication. Ensure regulatory compliance in respect of pharmacovigilance. To work in accordance to GLP. To intimate any discrepancy in conduct of trial.
Develop capabilities and competencies in the assigned technical requirement within RAD. Make recommendations to Corporate Drug Safety Committee, as required. Field staff Training.
Incumbent will work closely with Sales and Manufacturing Departments, as well.
Must have experience in preparation of dossiers.
The candidate will perform data entry, data clean up, and data loading to maintain and expand a commercially successful database of available chemicals. Responsible for providing regulatory input for projects and co-coordinating and compiling product submissions to the assigned markets.
Field staff Training. Ensure that the global pharmacovigilance database is updated periodically.
Degree: Life science degree expected with particular focus on virology.
Develop capabilities and competencies in the assigned technical requirement within RAD. Participate in company core data sheets and product label changes and medical interpretation of safety data for regulatory documents. Online project guidance is our main peculiarity. Prepare reports of PMS studies for regulatory submission. Responsible for planning, designing and executing clinical protocols supporting a specific therapeutic such as Oncology, Cardiology, Rheumatology or Neurology.