Amee Pandya
Medical Monitor @Indero (formerly Innovaderm)
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WORK HISTORY
Medical Monitor @Indero (formerly Innovaderm)
ON, CA
Working in therapeutic area of Dermatology for Phase 1-4 Clinical trials Review of study protocols, amendments, the Investigator\'s BrochureCreate or review the Medical Monitoring plan.Conduct training for the project team on the study protocol and therapeutic area.Deliver continuous medical support to investigators and site staff.Offer guidance on protocol-related inquiries, including inclusion/exclusion criteria and prohibited medications.Evaluate lab critical values and alerts.Provide medical consultation during business hours and escalate significant safety issues.Attend and present at Investigator meetings and SIVs.Assess safety profiles and review safety data for trends and unreported deviations.Ensure proper coding of adverse events and assess stopping rules.
EDUCATION
Gujarat University
Doctor of Medicine - MD, Clinical Pharmacology from Smt. NHL Municipal Medical College
Gujarat Adani Institute of Medical Science
Bachelor of Medicine, Bachelor of Surgery - MBBS
ABOUT AMEE PANDYA
Experienced health care professional with 9 years of experience in patient management, clinical research, medical monitoring and drug safety.Robust experience in Drug safety and Pharmacovigilance with expertise in ICSRs, aggregate reporting and case narratives. Extensive experience with quality review related to IB, Protocols, labeling and narrative writing. Significant experience with patient eligibility review; and review eligibility package, imaging and SAE data reconciliation, protocol deviation management, SIVs, scientific and SRC meetings. Experienced in preparation of cohort reports and updating clinical sections of the IB, DSUR, manuscripts, clinical development plan, medical monitoring plan, data management plan, safety management plan and clinical study report(s) Perform final review of site-specific data listings for database lock approval and provide protocol training for third parties as required (e.g, CRA and study site staff) Provide in-depth analysis and scientific input into development and execution of protocols and medical monitoring plan.Therapeutic areas: Oncology, Rare diseases, Endocrinology, Vaccines, Cardiology, Dermatology, Rheumatology, Respiratory and Women\'s health.
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