Suchi Patel

Experience

1. Senior Pharmacovigilance Specialist

   ProPharma

   Oct 2021 — Present

   Pharmacovigilance Specialist | ProPharma Group, Remote Worker\\\\nOct 2021 – Present\\\\nServing the role of a global literature team lead from the US for the Novavax COVID vaccine and managing multiple direct reports, which serve as PC coordinators, PV specialists, and Submission specialists.\\\\nManage global and local literature safety surveillance, case processing, signal management,signal detection, aggregate reports, PSURs and DSURs.\\\\nKey contributor to Safety Profiling Teams to ensure that case reports are accurately evaluated and databased and manage ad-hoc safety queries.\\\\nSupport the signal management process, including signal tracking, leading review meetings, and evaluating safety data as part of ongoing pharmacovigilance activities.\\\\nServe as a core member of the Safety Management team, including facilitating discussions, producing data outputs, and preparing presentations.\\\\nPerforming in-line case QC review, including report type/reportability, event Med-DRA coding, seriousness, and expectedness at the event and case level.\\\\nWriting case narratives and reviewing Med Watch/CIOMS/E2B forms.\\\\nMaintaining an understanding of and ensuring compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans, and the drug development process.\\\\nWorking on Safety database and Literature databases, such as Oracle Argus Safety 7.1.6,8.0.1, ARISg 7.1.1, Embase, and PubMed.\\\\n Leading Investigation of issues to identify the root cause and proposed Corrective Action Plan Activities (CAPA)/deviation\\\\nreports.\\\\n Develop training materials and conduct training presentations and on-the-job training for Pharmacovigilance staff.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n