Ali Anwar
Medical Director - Patient Safety, Device and Combination Products @Novo Nordisk
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WORK HISTORY
Medical Director - Patient Safety, Device and Combination Products @Novo Nordisk
Plainsboro, NJ, US
EDUCATION
ECFMG Certification
Doctor of Medicine - MD
Kasturba Medical College, Manipal
Doctor of Medicine - MD
American International Medical University
Medical Doctor, Clinical Medicine
ABOUT ALI ANWAR
Physician with expertise in monitoring patient safety across development and marketed drugs. Develop Pre-NDA risk assessment/signal detection strategies for monitoring clinical safety. Lead post-marketing risk management plans, safety issue crisis management, medical review, and signal translation including safety analysis and risk evaluation. Collaborate with regulatory affairs and other functional areas to design, implement and oversee risk mitigation strategies (Risk Management Plans, and Post-Marketing Evaluation Programs) to ensure the safe and appropriate use of company products in compliance with global legal and regulatory requirements. Contributed as a safety expert in developing periodic reports as required (DSURs, PBRERs, ASRs). Performed signal detection from the internal safety database and FDAs AERS database and literature reports for marketed products. Successfully established signal detection and risk assessment processes for marketed products. Successfully developed and implemented risk identification and escalation processes for investigational products. Experience with a wide range of indications (Oncology, Gastroenterology, Neurology, and Endocrinology)
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