Bharath Kumar Nalla
Lead - Senior PV Safety Systems Analyst, ARISg, LSMV, Safety Systems Validation, SME
- Role
- Manager Pv Safety System at Johnson & Johnson Innovative Medicine
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
Experience
Manager Pv Safety System
Johnson & Johnson Innovative Medicine
Nov 2025 — Present · Hyderabad, IN
Coordinate with stakeholders to ensure efficient day-to-day operations of PV Systems, in alignment with global business requirements.Coordinate the resolution of any operational issues or system defects that arise after system releases or upgrades. Work closely with IT and business units to track and resolve any deviations, ensuring minimal disruption to PV processes and ongoing system functionality.Execute post-go-live monitoring plans to ensure that all system deployments are functioning as expected. Identify any performance gaps or system deficiencies and escalate these issues as needed.Ensure adherence to PV systems data standards, promoting data accuracy, consistency, and compliance across all systems and processes.Manage the integrity of the data within the safety database, including managing database transfers into the safety databaseManage operational projects impacting the safety systems and associated processes.Lead investigations into any late safety case reports, identifying root causes, and implementing corrective actions to prevent future occurrences. Collaborate with IT and cross-functional teams to ensure timely and effective closure of CAPAs, maintaining adherence to timelines and standards.Maintain an inventory of all PV systems aligned with the Pharmacovigilance Systems Master File.Communicate PV system releases/ upgrades and compliance and performance metrics to the appropriate groups.Participate in PV Audits and InspectionsSupport the maintenance of GxP/GMP compliance for PV systems, ensuring day-to-day operational adherence to global industry regulations under the guidance of senior leadership.Assess the impact of emerging global regulations on PV systems, data integrity, and operational standards. Recommend remedial actions to maintain compliance and data quality.Work with IT and cross-functional teams to implement innovative solutions in alignment with strategic goals set by leadership.
Education
Osmania University
M.Pharm
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