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Clinical Safety & Pharmacovigilance

Clinical Safety Services >

Postmarketed Pharmacovigilance Services >

Innovation & Technology >

Clinical SAE Processing & Expedited Reporting

Investigator Brochures Authoring and Updating

Medical Review of SAE

Global and Local Medical Literature Monitoring

Medical Monitoring

Signal Detection & Signal Management

Development Safety Update Report (DSUR) Authoring

Reconciliation with Partners, Clinical Database

Responsible Person for Pharmacovigilance (RPPV)

CSR Narratives Authoring

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting

Case Intake, Processing, Submissions, & Medical Review

Aggregate Reports – PSUR, PBRER, ASR, PADER, Report Calendar Management & Submission

Risk Management Plan (RMP), Risk Minimization & REMs

Global and Local Medical Literature Monitoring

Responsible Person for Pharmacovigilance (RPPV), Qualified Person for Pharmacovigilance & Global Local Safety Support

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting

Hosted Drug Safety Database – ArisGlobal LSMV™, LSRA™, ARGUS™ & Veeva Safety™

Global & Local Literature Management Platform – UNITY™ai.Lit

Integrated MICC Platform – Medical Information, Product Complaints & AE Processing

Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

Safety Case Intake & Case Processing Platform – AnyForm, AnyLanguage & AnySystem

Managed Services, Hosting & Reporting for Drug Safety

Pharmacovigilance Partners Agreements (PVA, SDEA) Management and Case Exchange – UNITY™dx

Validation and CSV Support

Clinical Documents Exchange Platform – UNITY™dx

Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting
Medical Affairs and Medical Writing

Medical Affairs and Medical Writing >

Innovation & Technology >

Multilingual Global Medical Information Call Center

Developing & Managing FAQs and Standard Response Letters

Developing Core Slide Decks

Systematic Literature Review

Posters and Abstracts

Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting

Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

Integrated MICC Platform – Medical Information, Product Complaints & AE Processing

Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting
Insights

Blogs >

White Papers >

News >

Case Studies >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Is it Drug Induced Liver Injury (DILI), or something else?

Medication Errors & Patient Safety – Part I

Postmarketing Adverse Drug Experience (PADE) Inspections – Part IV

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Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting

Reference Safety Information in Clinical Trials

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Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting

Soterius appoints Dr. Sumit Verma, MD, DNB to lead operations

Soterius : What does it mean ? When did it begin ?

Soterius appoints its first CEO

Soterius will attend World Drug Safety Congress – Europe

Soterius Expands US Operations

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Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

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Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting
Events

Upcoming Meetings & Webinars >

Past Meetings & Webinars >

DIA 2026 Global Annual Meeting

Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting

Soterius at German Pharmacovigilance Day 2025

Drug Information and Association Conference, Congress Centre Basel, Switzerland

Drug Information and Association Conference, Hilton Baltimore Inner Harbor, Baltimore, USA

World Drug Safety Congress- Americas, Boston Convention and Exhibition Centre, Boston, MA

World Drug Safety Congress- Europe, RAI- Amsterdam

World Drug Safety Congress – Americas, Boston, Massachusetts, USA

World Drug Safety Congress, Amsterdam, Europe

Resources >

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting
About Us

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Our Global Experts

Contact Us

Careers

Corporate Social Responsibility

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Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Events >

DIA 2026 Global Annual Meeting