Mriganka Chatterjee

About Mriganka Chatterjee

With 17+ years of total industry experience and 15 years of deep expertise in Pharmakovigilanz and Arzneimittelsicherheit, I specialize in managing and strengthening global PV systems, post‑market safety processes, and cross‑functional safety operations. In my current role as External Vigilance Alliance Manager at Novartis, I lead global partnerships and ensure compliance, operational excellence, and seamless collaboration across internal and external stakeholders.I bring a strong track record in:• End‑to‑end global pharmacovigilance operations (case management, signal detection, benefit–risk evaluation)• GVP compliance, audits, inspections, and post‑market safety surveillance• Alliance and vendor management, ensuring high‑quality delivery and consistent global standards• Complex problem‑solving, root‑cause analysis, and process improvement• Cross‑functional leadership across scientific, regulatory, medical, and operational teamsKnown for an analytical, structured, and solution‑oriented approach, I am often consulted to resolve issues requiring deep PV system understanding. I thrive in high‑pressure, multinational environments and deliver results with precision, quality, and clear communication.Driven by continuous learning and professional growth, I aim to contribute to organizations committed to patient safety, compliance, and innovation in global drug safety.

Experience

1. External Vigilance Alliance Manager

   诺华

   Jan 2023 — Present · Hyderabad, IN

   Staying abreast with current and emerging regulations and guidelines related to pharmacovigilance and/or device vigilance, offering expertise and guidance to internal teams and external partners regarding contractual arrangements, co-development agreements, full marketing agreements, as well as providing support for Clinical Trial Supply Agreements and local vigilance agreements as needed.• Conducting risk assessments of new deals to evaluate potential partner’s pharmacovigilance (PV) systems.• Overseeing global vigilance agreements with external business partners and vendors, leading negotiation teams to establish terms and conditions of these agreements.• Maintaining regular communication with key customers to ensure compliance with agreements, foster positive relationships, and serve as primary contact for both external and internal stakeholders to identify needs and resolve issues.• Productively communicating requirements with internal and external teams to certify adherence to global vigilance agreements and vendor contracts, monitoring compliance and reconciliation issues, and superintending corrective and preventive actions (CAPA) to validate continuous augmentation and maintain high compliance standards.• Contributing to ongoing process and obedience ameliorations, such as supporting quality management system (QMS), addressing deviations, root cause analyses (RCA), CAPA for non-compliance, and periodically updating Standard Operating Procedures (SOPs) and work instructions.

Education

• Ramakrishna Vivekananda Mission Vidyabhavan

  Secondary, 10+

• West Bengal University of Technology, Kolkata

  Bachelor's Degree, Pharmacy

• Agarpara Mahajati Vidyapith

  Higher Secondary, Science

• University of Greenwich

  Master's Degree, Pharmaceutical Sciences