Senior Executive - Drug Safety
To contribute to feasibility surveys. To act as a Medical and Safety Monitor on projects.
The key responsibilities of this position are
- Conduct feasibility studies in assigned geographies. Feasibility would include basic feasibility, top line feasibility,
detailed feasibility, On site survey, epidemiology survey, and other related activities as required to support Clinical
Operations and Projects etc.
- Provide medical inputs for feasibilities.
- Identify the sites to be contacted in consultation with members of Clinical Operations.
- Obtain information from investigators telephonically or through feasibility questionnaire, whichever applicable.
- Evaluate feasibility of a given study and suggest recruitment projections.
- Prepare feasibility report wherever applicable.
- Perform on site feasibility visits when required.
- Maintain and electronically archive data for future reference.
- Maintain feasibility, investigator, site and related databases.
- Provide support to clinical operations in conducting site qualification visits (SVQs).
Act as a Medical and Safety Monitor on projects:
- Review study related documents like Protocol (with amendments, if any), Investigator's Brochure, Informed Consent Form and Case
Report Form and provide inputs as applicable.
- Prepare Medical Monitoring Plan and the applicable associated documents like eligibility assessment form/ randomization forms.
- Attend study related meetings with the Sponsor.
- Prepare Safety Management Plan in accordance with SIRO/applicable Standard Operating Procedures (SOP), Good Clinical Practice,
local applicable regulations and scope of the services per contract.
- Prepare safety reporting presentation for the investigators' meeting (IM) and Site Initiation Visit (SIV). If required, make
presentation at the IM.
- Train the project team on Protocol, Therapeutic area and safety requirements of the study.
- Medically review the Serious Adverse Event (SAE) reports and supervise the activities of the Drug Safety Associate to ensure
compliance as per the safety management plan.
- SAE, expedite and Pregnancy reporting as applicable.