Medical Advisor (Pharmacovigilance)

We are looking for a Team lead / Manager / senior medical advisor / reviewer proficient in all aspects of clinical and post-marketing drug safety.

Clinical Phase :

• Lead as a medical monitor / Medical expert
• Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential.
• Review and provide feedback on study protocols as needed.
• Deliver therapeutic area training for all case processing team.
• May require 24 / 7 availability depending on the client needs for possible queries or protocol deviations resulting in potential harm to patients.
• Drafting medical monitoring plans (MMP) and ensuring compliance.
• Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).
• Make assessments on SUSAR reportability.
• Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).
• Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.

Post-Marketing (Pharmacovigilance) :

Required education : MBBS, or MD (Doctor of Medicine)

Required experience :

Required technical skills :