Shailesh Bondade
Executives Medical Director, Patient Safety and Pharmacovigilance @Ionis Pharmaceuticals, Inc.
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WORK HISTORY
Executives Medical Director, Patient Safety and Pharmacovigilance @Ionis Pharmaceuticals, Inc.
CA, US
Provide expertise in all the area of pharmacovigilance, leading Signal detection & risk management activities, Safety surveillance of ongoing Clinical Trials, Medical review of ICSR, and Aggregate reports including PBRER, DSUR, & PADER.
EDUCATION
Government Medical College, Nagpur, India.
Doctor of Medicine (MD), Medicine
ITU, USA
Masters in Healthcare Management, Masters in Healthcare Management
Institute of Psycho Management Studies, Nagpur. India.
Post Graduate Diploma, Counseling and Psychotherapy
ABOUT SHAILESH BONDADE
18 years of experience in healthcare sector including 15 years of experience in pharmacovigilance and risk management.• Comprehensive experience working in NDA and BLA submissions, including 2.7.4 Summary of Clinical Safety, labeling documents preparation, safety justifications for labeling changes, safety discussions & negotiations with health agencies, providing response to query (RTQs) for health agencies, etc. • Led signal detection and risk management activities for designated global products.• Medical review of ICSR cases that include medical evaluation causality assessment, listedness, seriousness, and coding.• Comprehensive experience working in multiple Safety databases – ARGUS, ARISg, and AWARE.• Safety surveillances for all phases of ongoing Clinical Trials and Medical Monitoring for early phase of Clinical Trials.• Led and contributed to the preparation of the Aggregate (Regulatory) Reports including PBRER, PADER, and DSUR.• Experienced in regulatory inspections / internal audits. Experienced in FDA inspection and advisory committee meetings for the approval of new investigational drug.• Led risk-benefit evaluations, the preparation and review of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in compliance with regulatory requirements.• Provided leadership and inputs for clinical development programs; worked closely with cross-functional departments, Contract Research Organizations (CROs), Business partners, and other entities to contribute towards overall study execution while ensuring safety strategy, quality, compliance and operational excellence.• Hands on experience in Medical writing. Worked on narrative section of CSR, 2.7.4 Summary of Clinical Safety, and aggregate reports.• Review of clinical documents - Clinical Study Protocols, Investigator\'s Brochure, CSR, IND and safety section of NDA/BLA.• Experienced in preparation of Reference Safety Information (RSI)/ Labeling documents (CCDS, USPI, SmPC and other country local monogram.) • Comprehensive knowledgeable with MedDRA coding and WHO Dictionary coding.• Good knowledgeable of good clinical practices (GCP), good pharmacovigilance practices (GVP) and regulations of FDA and EMA.• Management of CRO in pharmacovigilance activities and assisting them to achieve all milestones within defined timeline.• Excellent skill to manage multiple projects with rapidly changing priorities and deadlines.• Adhere to CAPAs from the Quality, Training, and Compliance group.
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