Amit Dubey

Pharmacovigilance, Enterprise Applications, Pharma IT, Medical Affairs Systems professional with 13+ years of experience managing global business-critical platforms, safety operations, regulated workflows, and cross-functional technology initiatives across GxP and non-GxP environments. Skilled in application ownership, ITSM, compliance governance, vendor coordination, data migration, release management, audit readiness, and operational improvement for enterprise healthcare and life sciences platforms. Recognized for combining deep pharmacovigilance and medical device vigilance domain knowledge with modern platform engineering, ServiceNow, Azure DevOps, Veeva, Salesforce-based applications, and secure integration practices to deliver compliant, stable, and business-aligned solutions.

Platform Engineer/ System Manager – Pharma IT at Astellas Pharma (2025-09 – Present)

• Serve as application/platform owner for enterprise Pharma- Medical Affairs systems supporting scientific publications, grants management, and Salesforce-based workflow platforms.
• Participate in Agile ceremonies including sprint planning, backlog refinement, daily stand-ups, sprint reviews, and retrospectives to support timely delivery of application enhancements and OKR's planning for next cycle.
• Translate business requirements into Epics, Features, User Stories, acceptance criteria, and functional inputs within Azure DevOps.
• Managing and leading daily operations, user support, production stability, incident resolution, change governance, and lifecycle activities for business-critical applications.
• Drive ServiceNow ITSM, Azure DevOps, ALM, release coordination, UAT planning, test execution support, and Agile delivery activities across Epics, Features, and User Stories.
• Maintain GxP, JSOX, CSV, SOP, Veeva Quality documentation, audit evidence, and inspection readiness standards for regulated application environments.
• Oversee SSO/SAML, IAM, TLS certificate coordination, access governance, UAR activities, third-party risk support, and application rationalization reviews.
• Coordinate with vendors, business stakeholders, infrastructure teams, and IT partners for issue resolution, renewals, contract inputs, service reviews, and operational governance.
• Support implementation, migration, data transfer, commissioning, decommissioning, CMDB updates, Ariba purchase/work order review, and system lifecycle documentation.
• Identify process gaps, strengthen operational controls, and support continuous improvement opportunities to improve platform reliability and user experience.
• Maintain and create SOP, data privacy, documentation, and inspection readiness standards.
• Participated in end-to-end Software Development Life Cycle (SDLC) activities including requirements gathering, solution design, testing, release management, production support, and system decommissioning.

Process Expert – Product Quality Surveillance at Alcon Laboratories (2023-08 – 2025-09)

• Led global medical device vigilance, complaint handling, case triage, case assessment, quality surveillance, and regulatory reporting activities across regulated markets.
• Managed case intake, triage, investigation, documentation, closure, and reporting activities including MIR, FDA 3500A, and EU MDR submissions within defined timelines.
• Improved process quality through RCA, FMEA, 5-Why analysis, defect tracking, corrective actions, and continuous improvement initiatives.
• Supported change adoption through training, documentation updates, and stakeholder communication.
• Supported SOP updates, training delivery, audit readiness, inspection preparation, knowledge transfer, and quality documentation standards.
• Created Power BI dashboards and operational reports to improve visibility into workload, compliance timelines, quality trends, and process performance.
• Collaborated with business, quality, safety, and technology teams to improve reporting visibility, governance, and inspection-ready operations.

Senior Patient Safety Specialist at Alcon Laboratories (2020-04 – 2023-08)

• Managed end-to-end ICSR processing for pharmaceutical, medical device, and literature cases with strong focus on quality, accuracy, compliance, and submission timelines.
• Executed global vigilance submissions including IVR, SMDR, MIR, and EU MDR reporting in alignment with applicable regulatory timelines.
• Supported CAPA activities, audit readiness, inspection preparation, documentation review, and process governance within patient safety operations.
• Monitored case quality, supported compliance tracking, coordinated with stakeholders, and contributed to continuous improvement initiatives.
• Performed upfront medical triage in Argus Safety and Trackwise, assessing seriousness, expectedness, causality, source completeness, follow-up requirements, and applicable regulatory reporting timelines.

Senior Drug Safety Associate at Bioclinica (Clario) (2017-11 – 2020-04)

• Processed ICSR cases in Oracle Argus, including case triage, data entry, MedDRA coding, narrative review, quality checks, and regulatory compliance review.
• Performed upfront medical triage in Argus Safety by assessing seriousness, expectedness, causality, source completeness, follow-up needs, and reporting timelines.
• Expedited reporting criteria, including seven-day and 15-day requirements, and assigned appropriate Argus workflows for timely case progression.
• Escalated complex cases to the Medical Reviewer and authored structured summaries covering clinical course, causality, and review considerations.
• Supported peer review, E2B compliance checks, defect tracking, audit documentation, case quality monitoring, and operational reporting.
• Maintained SOP, data privacy, documentation, and inspection readiness standards while exploring artificial intelligence opportunities to improve operational efficiency.

Medical Safety Specialist at Cognizant (2016-02 – 2017-10)

• Processed drug and device adverse event cases using ArisG and MedDRA while ensuring case quality, compliance timelines, and client deliverables.
• Supported signal detection activities, regulatory reporting, case prioritization, query resolution, and safety documentation review.
• Delivered training, knowledge sharing, and client coordination to support operational consistency and timely pharmacovigilance delivery.
• Collaborated with internal teams and client stakeholders to resolve workflow issues and strengthen regulatory case processing outcomes.
• Escalated complex or medically significant cases to the Medical Reviewer and prepared structured case summaries covering clinical course, causality assessment, and review considerations.

Pharmacovigilance Associate at Symogen Pvt. Ltd. (2013-11 – 2016-02)

• Processed clinical trial and post-marketing ICSR cases in ArisG, including triage, coding, narrative writing, case documentation, and quality review support.
• Contributed to PSUR, PBRER, aggregate reports, regulatory documentation, and timely delivery of pharmacovigilance activities.
• Built foundational expertise in safety database workflows, medical coding, case lifecycle management, and compliance-focused case processing.

Bachelor of Pharmacy in Pharmacy – Amity University (2009 – 2013)