Chintan Patel Email & Phone Number

Extensive experience in Pharmaceutical industry: Pharmacovigilance experience - Clinical trials, Spontaneous reports from post marketing surveillance, License partner cases, Literature cases and Litigation cases.Detail knowledge of Drug Safety and Clinical Research Activities.Detail knowledge of Quality and Compliance activities and Late Case Investigations.Detail knowledge of Outsourcing, External Partner Management and Negotiations.Experienced in Oncology, Cardio Vascular, Neurology, Dermatology, Consumer Care, Female Healthcare, Medical Devices, Combination Products, Diagnostics and Pain Management therapeutic areas.Extensively reviewed and retrieved drug safety information from medical records.Good understanding and knowledge of clinical trial process, drug development process and clinical development plans.Experience with ARGUS safety database, IRMS Database, PV Monitor, Trackwise compliance tools.Experience with US FDA and EMEA regulations, compliance with time lines, case report submission, adverse events reporting, review source documents and the labels.Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.Experience in handling the reports from various countries including Europe and Asia.Experience in AE coding with MedDRA. Experience in coding with WHODD dictionary.Command over drug development process and clinical development plans through years of experience and training.Appreciated for capturing all the events in the reports and generating concise and accurate narratives.Comfortable working in an evolving role.Self-motivated and focused achiever dedicated to producing consistently superior outcomes.Team player with ability to function in a multi-disciplinary environment.Analytical, accurate and detail-oriented in ensuring the success of the project as per the guidelines and time frames.