Dharmesh Murabia

About Dharmesh Murabia

As a strategic-thinking Leader in Safety Sciences, I have steered and grown the pharmaco- and safety vigilance organizations for global healthcare corporations, such as Haleon, GSK Consumer Healthcare, and Novartis in India and Poland.Led Veeva Safety database planning and implementation for Case processing, Medical safety including signal and report authoring capabilities for Haleon, SandozThroughout my 15+ year career, I have led PV protocols performance and compliance with global regulatory requirements. Being a strategic Leader with advanced communication and engagement skills, I have consistently monitored CRO/vendor(s) PV activities, including Safety Management Plans, Signal Management and reporting, and aggregate report preparation.As a key member of the Clinical Research Group, I have provided strategic medical safety leadership for assigned product(s) in a cross-functional setting.

Experience

1. Head Case Management and Aggregate Reports - Director

   Sandoz

   Mar 2025 — Present · Hyderabad, IN

   Accountable for development and deployment of the Sandoz safety case management and aggregate reporting strategy in close collaboration with Head Patient Safety Operations & Compliance. This includes Leading and developing team, responsible for oversight and control of all clinical trial and postmarketing safety cases handled by Sandoz’s and its strategic suppliers. Leading and developing team, responsible for oversight and control of all aggregate reports handledby Sandoz’s and its strategic suppliers. Ensure compliance with reporting timelines and quality standards which are under the control ofpatient safety operations. Manage strategic interfaces with other internal and external stakeholders (e.g, Global line functionsenior management, investigator sites, Vigilance Agreement Partners (VAP) to ensure consistentprocesses, efficient handling of safety case reporting, aggregate reporting,

Education

• C.H.M college

  HSC

• Fatima High School

  SSC

• Terna Medical College

  M.B.B.S

Skills

• Standard Operating Procedure (Sop)
• U.s. Food and Drug Administration (Fda)
• Medicine
• Regulatory Requirements
• Clinical Trials
• Gcp
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Regulatory Affairs
• Biotechnology
• 21 Cfr Part 11
• Quality Assurance
• Oncology
• Protocol
• Software Documentation
• Pharmacology
• U.s. Title 21 Cfr Part 11 Regulation
• Medical Writing
• Ich-Gcp
• V&V
• CRO
• Clinical Research
• Medical Review
• Regulatory Submissions
• Data Management
• Pharmacovigilance
• Gmp
• Life Sciences
• Pharmaceutics
• Employee Engagement
• Good Clinical Practice (Gcp)
• CRO Management
• Validation