Essential Functions: The following duties represent the principal job duties however they are not all inclusive:
Updation and maintenance of all the safety related files of the department
Ensure that appropriate Safety related documents are complete and appropriately filed
Assist in follow up of all SAE related information/ queries from the respective sites
Communicate with the sites to collect the information/ queries within the specified timelines
Assist in the preparation of safety narratives
Assist the Medical monitors in preparation of safety related documents (SMPs/ Presentations/etc)
Ensure timely & accurate updates and maintaining SAE related trackers/ software (if any)
Assist the medical monitors & safety in solving study related queries and providing latest information through web search




To assist in solving the internal QA findings and CAPA closure
Assist the Study Team to assure compliance with protocol requirements, FDA regulations, Valuable Clinical Practice and Safety Management Plan
Any other duties as assigned by the supervisor in the department.

Skills and Qualifications:

Knowledge of:
1 Years CR experience
B.D.S./BHMS/MDS
Understanding of safety reporting / PV database etc.
MS Office
Requirements of Valuable Clinical Practices
Requirements of Valuable Documentation Practices
Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

📌 Safety Associate Clinical Trials Faridabad (India)
🏢 JSS Medical Research
📍 India