Role & responsibilities

1 Review of the screening reports, randomization request, safety data and various medical reports during the study conduct.

2 Conduct study feasibilities (preliminary and detailed) for the clinical trials as per the proposal from sponsor and preparation of feasibility questionnaire (Questionnaire related to Study patient population).

3 Review/Preparation of clinical trial documents for domestic and global regulatory submission (e.g., Protocol Synopsis, Study Protocols etc.)

4 Preparation of Safety management plan, Medical monitoring plan, Risk mitigation and management strategy, Safety reporting forms (SAE form, Table 5 and Sponsor opinion letter etc.).

5 Review of serious adverse event form, Table 5 and pregnancy forms prepared by site and coordinating safety reporting for maintaining timelines as per regulatory requirement and protocol.

6 Review of various safety and efficacy data generated during the clinical study.

7 Review of AE and concomitant medication details before data base lock and coordination with data management for the same and providing medical inputs to DM.

8 Maintaining the SAE Trackers.

9 Providing the Therapeutic Training/Safety reporting training to Monitors and site

10 Providing the adequate response to investigators query related to medical aspects and response to investigator to address the EC queries related to study.





11 Perform Site visit to train the site and performing on site medical monitoring visit as and when required.

12 CTRI Registration and timely update of the same on CTRI Portal

13 Completion of any other task assigned by the Reporting Head Medical Affairs & Pharmacovigilance.

Pharmacovigilance Job Responsibilities

1 Medical review of valid/non-valid ICSR.

2 Medical review of the PADER, PSUR and ACOs including case analysis and evaluation of overall risk-benefit profile.

3 Sign the final ACOs and endorsing the final conclusion of the ACOs.

4 Preparation of clinical expert statement (CES), which shall be submitted along with ACOs.

5 Overall assessment of RMP including assessment of significant identified and potential risks.

6 To approve/reject selected ICSRs and AOI from literature screening.

7 To request and approve ordering of full text articles and translation. To conduct follow up with author when deemed necessary.

8 Review of literature articles/published studies log, Reference safety information (RSI) or its equivalent, Conclusion of previous periodic reports (if applicable) and Assessment reports previously received from the competent authorities.

9 To collect and document of any new or significant safety information identified during medical/scientific review.

📌 Medical Monitor (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad