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Accelerating Innovation & Compliance

Technology-Enabled Drug Safety, Pharmacovigilance and Medical Affairs Services

We are Soterius – a strong team of experienced professionals from the pharma industry. We design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up-to-date insights let us combine agile, people-powered intelligence with big data in pioneering customer-centric solutions.

Banner for Soterius: Pharmacovigilance & Medical Affairs Experts

90+

Regulatory Inspections supported by the team

300+

Group employees out of 3 continents

50+

Clinical Trial Sites currently active on UNITYdx™

2,200+

Aggregate Reports for Submission in 65+ countires

>30%

Savings typically achieved through automation

3,000+

Signalling Reports

3.80%

Lowest Industrywide Staff Turnover Rate

50+

Active Clinical Trials

60+

Countries with LSO/LRP & Local MI/PQC/AE Reporting

300+

Post-Marketing Products

210,000

Annual Cases Medical Triage & Review

99.99%

Submission Compliance/According to Client Metrics

Soterius Expertise

We have a truly global presence capable of handling complete pharmacovigilance support and medical affairs across multiple geographies.

Clinical Safety Services

Postmarketed Pharmacovigilance Services

Medical Affairs and Medical Writing

Innovation & Technology

What Our Clients Say?

CONNECT WITH US

Head of Medical Affairs Division

Top 5 Pharma

"Experts – with Services and Technology Offerings"

Head of PV

Global Pharma Company

"Uber of Drug Safety"

Board Member

Top 10 Global Generic Company

"Cost-Effective through innovation, not just cost-cutting"

Head of Global Medical Affairs

Top 10 Global Pharma

"Re-Defining Pharmacoadherence"

Culture at Soterius

Soterius celebrates diversity, fostering an inclusive, collaborative culture where global teams unite to drive excellence in drug safety and medical affairs. We are fiercely centered at building a positive work-space for our colleagues to help deliver the most engaged service experiences for our clients.

Culture at Soterius

People at Soterius

People at Soterius

Highly experienced and motivated colleagues, many of whom have ownership interests in our company, ensure our clients receive innovative solutions that maximize efficiencies and compliance.

Come Join us

When you work at Soterius, you experience and work with the industry's foremost leaders in drug safety and medical affairs. Our clients range from the top global companies to the highly localized or niche pharma companies. We reward good performance and support learning and professional growth for all.

Come Join us

Postmarketing Adverse Drug Experience (PADE) Inspections – Part IV

Written Response May be considered in an FDA compliance decision.…

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

Legal Framework of PADE Inspections Scientific Literature Reports Determine: If…

Postmarketing Adverse Drug Experience (PADE) Inspections – Part II

Ref: Postmarketing Drug Safety and Inspection Readiness June 19, 2018.…

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Once a drug is approved, applicant holders MUST receive, evaluate,…

Audits in Pharmacovigilance: A commitment to Safety

In the realm of healthcare, ensuring patient safety is the…

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

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

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

Multilingual Global Medical Information Call Center

Developing & Managing FAQs and Standard Response Letters

Developing Core Slide Decks

Systematic Literature Review

Posters and Abstracts

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

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

Postmarketing Adverse Drug Experience (PADE) Inspections – Part IV

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

Postmarketing Adverse Drug Experience (PADE) Inspections – Part II

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Audits in Pharmacovigilance: A commitment to Safety

Reference Safety Information in Clinical Trials

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

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

World Drug Safety Congress, Europe 2025

World Drug Safety Congress, Americas 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

Our Global Experts

Contact Us

Careers

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

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

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