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, Good 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 Good Clinical Practices
- Requirements of Valuable Documentation Practices
- Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

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