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Clinical Safety & Pharmacovigilance

Clinical Safety Services >

Postmarketed Pharmacovigilance Services >

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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 >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany

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 >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany

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 >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany
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 >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany

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

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

Resources >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany
Insights

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Case Studies >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Postmarketing Adverse Drug Experience (PADE) Inspections – Part II

Post marketing Adverse Drug Experience (PADE) Inspections – Part III

Hy’s law & Drug Induced Liver Injury – Part II

Hy’s law & Drug Induced Liver Injury – Part I

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Resources >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany

Reference Safety Information in Clinical Trials

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Resources >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany

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

Top 5 Global Pharma Company Trusts Soterius with Providing Time-Sensitive Medical and Scientific Services

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Resources >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

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Resources >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany
Events

Upcoming Meetings & Webinars >

Past Meetings & Webinars >

German Pharmacovigilance Day, Frankfurt am Main, Germany

World Drug Safety Congress, Europe 2025

World Drug Safety Congress, Americas 2025

Resources >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany

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 >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany
About Us

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Resources >

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Events >

German Pharmacovigilance Day, Frankfurt am Main, Germany