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Anthony Elia

@anthonyelia

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Senior pharmacovigilance leader driving global safety operations, compliance, and scalable PV strategies.

United States

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What I'm looking for

I’m looking to lead global pharmacovigilance operations where I can optimize processes, manage outsourced PV partners, strengthen regulatory compliance, and deliver scalable, risk-based safety strategies that protect patients.

I’m a PharmD and Board Certified Medical Affairs Specialist who has led global pharmacovigilance operations for 10+ years across clinical development and post-marketing safety. I drive strategic oversight of pharmacovigilance programs, ensuring global safety compliance, inspection readiness, and end-to-end operational leadership in complex, highly regulated environments.

I’m known for operational excellence through process optimization, cross-functional collaboration, and proactive risk management. My expertise spans Argus Safety Database and Veeva Vault, safety system migrations, automated compliance monitoring, CAPA management, and vendor/CRO governance—so teams can deliver scalable safety strategies that support business objectives and patient safety.

Experience

Work history, roles, and key accomplishments

Clinical & Global PV Operations

Merck & Co

May 2017 - Nov 2025 (8 years 6 months)

Directed global pharmacovigilance operations across clinical development and post-marketing programs, including oversight of outsourced PV activities and cross-functional alignment. Managed global safety compliance (ICSR lifecycle, SUSAR/expedited reporting), vendor governance, inspection readiness, and supported Argus-to-Veeva safety system migration and compliance automation.

Pharmacovigilance Global PV Operations Clinical Trial PV Oversight Post Marketing Safety PVA SDEA Agreements ICSR Lifecycle Management SAE Reconciliation SUSAR And Expedited Reporting Compliance Veeva Vault CAPA Management Inspection Readiness Audit Support SOP Development

Senior Drug Safety Associate

Janssen Pharmaceuticals

Oct 2016 - May 2017 (7 months)

Responsible for receipt and data entry of adverse event reports, ensuring compliance with SOPs and worldwide safety regulations. Triaged and classified ICSRs and supported product quality complaint reporting accuracy for CNTO, Anti-Infective, and CNS products.

ICSR Triage ICSR Classification (Report Type Seriousness Causality Expectedness)Regulatory Compliance

Teaching Associate

Duquesne University

Jan 2013 - Jan 2015 (2 years)

Lectured university-level courses in Drug Design, SAR, ADME, and Synthetic Chemistry.

Drug Design SARs Synthetic Chemistry Lecturing

Research Associate

Duquesne University

Jan 2013 - Jan 2015 (2 years)

Conducted synthesis and testing of novel Folate Receptor anti-cancer drugs, including NMR and PK/PD assays and compound documentation.

NMR PK PD Assays Folate Receptor Anti Cancer Drug Research

Applications, Research & Tech Svcs

SPI Pharmaceuticals

Jun 2012 - Jul 2013 (1 year 1 month)

Conducted design and execution of formulation experiments to optimize tablet physicals and manufacturing parameters. Supported drug product formulation using design of experiment techniques.

Drug Product Tablet Physicals Optimization Manufacturing Parameter Optimization