Pranit Bhat Email & Phone Number

• Manage the Team of Patient Safety Coordinators Patient Safety Specialists, and Patient Safety Associates.• Manage the Team in order to ensure appropriate collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing surveillance (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.• Act as Deputy Qualified Person for Pharmacovigilance in Novartis Country Organizastion COUNTRY as defined by local regulation and manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk benefit) to Local Health Authorities (LHA) according to regulatory requirements.• Acts as Patient Safety Country Head Deputy: *functional (in terms of responsibility for PV system) and operational (in terms of managing the PS Team).• Participate in Site audits with Clinical research Medical advisor at clinical research sites for anytime audit readiness practice.• Maintains the oversight in order to ensure that reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, SUSAR, IN, PSUR, DSUR, changes in risk benefit) is done according to the timeliness described into the respective procedures.• Work with other local/global PS and Medical Safety associates to ensure accurate evaluation of safety data.• Interact and exchange relevant safety information with local health Authority (LHA), PS associates, other functional groups and third party contractor, if applicable.• Survey and monitor national pharmacovigilance regulations and provide update to global PS organization.• Set up, update and implement local procedures to ensure compliance with PS global procedures and national requirements.

Listed skills include Pharmacovigilance, Quality Assurance, Drug Safety, Ich Gcp, and 10 others.

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  University Of Pune

  B.Pharmacy