How you’ll spend your day
Literature search, preparation of Clinical study protocols and PSP according to required day to day Guidelines and Regulatory Requirements by using Product Monographs/Prescribing Information/Summary of Product Characteristics etc., as applicable.
Preparation of Informed Consent Form/s (ICF) in line with Clinical study protocol.
MedDRA and WHO-DD coding of clinical studies
Preparation/review of Case Record Forms (CRF).
System improvements as basis.
Preparation of Clinical Study Reports.
Your experience and qualifications
M.Pharm (Pharmacology)
1-2 Years of experience into protocol writing