Pharmacovigilance

The Global PV Challenge

The Mandate: Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/device-related problem.
The Challenge:
- Regulatory Complexity: Constantly evolving Good Pharmacovigilance Practices (GVP) and mandatory reporting deadlines (e.g., 24-hour, 7-day, 15-day) across 100+ countries (FDA, EMA, MHRA, PMDA, CDSCO, etc.).
- Data Volume: Exponential increase in safety data from clinical trials, spontaneous reports, literature, and digital sources.
- Resource Strain: Maintaining a 24/7 global safety infrastructure with the required medical and scientific expertise is complex and costly.

We act as your mandatory regulatory safety contact in key markets.

EU QPPV (Qualified Person for Pharmacovigilance): Appointment and oversight of the mandatory QPPV for the European Economic Area (EEA), responsible for the PV system and the PSMF.
Local PV Contacts (LPPVs): Appointment of required local safety contact persons across EU Member States and other territories (e.g., Australia, Canada, APAC).
Global Regulatory Intelligence: Continuous monitoring and rapid adaptation to local regulatory changes in 100+ jurisdictions.
Audit & Inspection Readiness: Conducting GVP Audits and providing support during HA inspections (FDA, EMA, etc.) to ensure sustained compliance.

We provide flexible, integrated, and technology-enabled PV solutions to transform your mandatory compliance into a competitive advantage.

Pillar	Our Commitment	Key Benefit to You
Expertise	Dedicated PV Physicians, Safety Scientists, and Regulatory Specialists with global experience.	Risk Mitigation: Proactive identification and management of safety signals.
Global Reach	24/7/365 operational hubs and local affiliates for country-specific reporting.	Guaranteed Compliance: on-time regulatory submission rates globally.
Technology	Use of validated, industry-leading safety databases (e.g., PV Edge, Clinevo, Argus, Veeva) and AI/NLP tools.	Efficiency & Quality: Reduced case processing time and enhanced data quality.

The foundation of compliance—efficient, high-quality management of Individual Case Safety Reports (ICSRs).

Global Case Intake: Receipt of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) from all sources (spontaneous, literature, clinical trials, digital).
End-to-End Case Processing:
- Triage, data entry, and narrative writing.
- Medical coding (using MedDRA and WHO-DD).
- Causality assessment and medical review by PV Physicians.
Global Regulatory Submissions: Expedited electronic reporting (e.g., ICH E2B standard) to all Health Authorities (HAs) and Ethics Committees (ECs).
Support for All Product Types: Pharmaceuticals, Biologics, Vaccines, and Medical Devices/IVDs (Vigilance).

Moving beyond reporting to proactive safety strategy and benefit-risk optimization.

Signal Detection & Management:
- Routine and ad-hoc analysis of pooled safety data to detect new or changing safety signals.
- Signal validation, prioritization, and tracking according to GVP Module IX.
Risk Management Solutions:
- Development and maintenance of Risk Management Plans (RMPs), including post-authorization safety studies (PASS).
- Implementation and effectiveness assessment of Risk Minimization Measures (RMMs).
- REMS (Risk Evaluation and Mitigation Strategy) support for the U.S. market.

Ensuring comprehensive documentation for maintaining market authorization worldwide.

Report Type	Focus	Key Purpose
Aggregate Reports	Worldwide safety summary over defined intervals.	Fulfilling global periodic reporting requirements.
Development Safety Update Report (DSUR)	Clinical Trials (Pre-Approval)	Reporting on the safety of investigational products.
Periodic Benefit-Risk Evaluation Report (PBRER) / PSUR	Marketed Products (Post-Approval)	Comprehensive assessment of benefit-risk balance.
Pharmacovigilance System Master File (PSMF)	Detailed PV System Description (EU)	Mandatory document proving the PV system is compliant with GVP.
Safety Writing	Ad-hoc reports, protocols, and regulatory queries.	Providing expert medical/scientific rationale for regulatory bodies.