Skip to content

Clinical Safety & Pharmacovigilance

Clinical Safety Services >

Postmarketed Pharmacovigilance Services >

Innovation & Technology >

Overview Clinical Safety Services & Technology Offerings

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 >

40th Pharmacovigilance UK & EU 2026

Overview Post-Marketing Safety 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 >

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

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

Overview Technology Offerings for Safety & Medical Information

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 >

40th Pharmacovigilance UK & EU 2026
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 >

40th Pharmacovigilance UK & EU 2026

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 >

40th Pharmacovigilance UK & EU 2026
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

See More

Resources >

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

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

Reference Safety Information in Clinical Trials

See More

Resources >

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

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

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 >

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

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

See More

Resources >

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

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026
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 >

40th Pharmacovigilance UK & EU 2026

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 >

40th Pharmacovigilance UK & EU 2026
About Us

About Us >

Our Global Experts

Contact Us

Careers

Corporate Social Responsibility

Resources >

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

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

Clinical Safety & Pharmacovigilance

Clinical Safety Services

Overview Clinical Safety Services & Technology Offerings

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

Postmarketed Pharmacovigilance Services

Overview Post-Marketing Safety 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 >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

Innovation & Technology

Overview Technology Offerings for Safety & Medical Information

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

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 >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

Innovation & Technology

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

Insights

Blogs

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

Resources >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

White Papers

Reference Safety Information in Clinical Trials

Resources >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

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 >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

Case Studies

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

Resources >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

Events

Upcoming Meetings & Webinars

DIA 2026 Global Annual Meeting

Resources >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

Past Meetings & Webinars

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

About Us

About Us

Our Global Experts

Contact Us

Careers

Corporate Social Responsibility

Resources >

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

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

Deploying an Inspection Ready AI System in PV

Deploying an Inspection Ready AI System in PV

Events >

40th Pharmacovigilance UK & EU 2026

40th Pharmacovigilance UK & EU 2026

CONTACT US

40th Pharmacovigilance UK & EU 2026

03/11/2026
Sheraton Skyline, Heathrow, London, UK

Connect with us

For Business Enquiries:

Δ

For any career-related enquiries, click here

For Career Enquiries:

Upload Resume (PDF/DOC)

Δ

For any business-related enquiries, click here

PHARMACOVIGILANCE

MEDICAL AFFAIRS

Terms & conditions

Clinical Safety Services

Overview Clinical Safety Services & Technology Offerings

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

Overview Post-Marketing Safety 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

Overview Technology Offerings for Safety & Medical Information

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

Copyright @ 2025 Soterius | All Rights Reserved

5 Independence Way, Suite #300
Princeton, NJ 08540

info@soterius.com
Phone: (212) 203 0450

Terms and Conditions
Privacy Policy