Medical Advisor/Associate Medical Director (Mumbai)

Medical Advisor/Associate Medical Director (Mumbai)

12 Oct
|
Iqvia
|
Mumbai

12 Oct

Iqvia

Mumbai

IQVIA is looking to appoint a Medical Advisor/Associate Medical Director to be part of our Medical Services team to deliver medical, clinical and scientific advisory expertise in clinical research studies. You will support compliance with protocol execution from a medical and scientific perspective. Also, you will provide medical expertise during project delivery lifecycles; provide medical support to project teams and investigative sites; clarify protocols and inclusion/exclusion determinations; advise around patient safety issues; perform medical reviews and clarifications of trial-related and post marketing studies Adverse Events; signal detection and aggregated reporting; and conducting project delivery lifecycles (pre-marketing and post-marketing).

Responsibilities:
• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
• Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.




• Contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
• Provide therapeutic area/indication training for the project clinical team.
• Attends and may present at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Reliable Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available 24

📌 Medical Advisor/Associate Medical Director (Mumbai)
🏢 Iqvia
📍 Mumbai

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