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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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day
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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

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

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

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day
Insights

Blogs >

White Papers >

News >

Case Studies >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

See More

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

Reference Safety Information in Clinical Trials

See More

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

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

See More

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

See More

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day
Events

Upcoming Meetings & Webinars >

Past Meetings & Webinars >

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

40th Pharmacovigilance UK & EU 2026

World Drug Safety Congress – Boston , Americas 2025

World Drug Safety Congress – Amsterdam, Europe 2025

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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day
About Us

About Us >

Our Global Experts

Contact Us

Careers

Corporate Social Responsibility

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Events >

German Pharmacovigilance Day

Clinical Safety & Pharmacovigilance

Clinical Safety Services

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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Postmarketed Pharmacovigilance Services

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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Innovation & Technology

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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Medical Affairs and Medical Writing

Medical Affairs and Medical Writing

Multilingual Global Medical Information Call Center

Developing & Managing FAQs and Standard Response Letters

Developing Core Slide Decks

Systematic Literature Review

Posters and Abstracts

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Innovation & Technology

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

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

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Insights

Blogs

Governance and Accountability in AI-Enabled Pharmacovigilance

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

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

White Papers

Reference Safety Information in Clinical Trials

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

News

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

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Case Studies

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Events

Upcoming Meetings & Webinars

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

Past Meetings & Webinars

40th Pharmacovigilance UK & EU 2026

World Drug Safety Congress – Boston , Americas 2025

World Drug Safety Congress – Amsterdam, Europe 2025

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 >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

About Us

About Us

Our Global Experts

Contact Us

Careers

Corporate Social Responsibility

Resources >

Governance and Accountability in AI-Enabled Pharmacovigilance

Governance and Accountability in AI-Enabled Pharmacovigilance

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

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

Events >

German Pharmacovigilance Day

German Pharmacovigilance Day

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World Patient Safety Congress Europe 2026

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German Pharmacovigilance Day

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PHARMACOVIGILANCE

MEDICAL AFFAIRS

Terms & conditions

Clinical Safety Services

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

Postmarketed Pharmacovigilance Services

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

Medical Affairs and Medical Writing

Multilingual Global Medical Information Call Center

Developing & Managing FAQs and Standard Response Letters

Developing Core Slide Decks

Systematic Literature Review

Posters and Abstracts

Innovation & Technology

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

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Phone: (212) 203 0450

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