Drug Safety & Pharmacovigilance

Reliable PV Systems for Patient Safety and Compliance

Magnus CRO delivers scalable pharmacovigilance services across development and post-marketing. We combine experienced case processors, safety physicians, and quality leads with validated systems and inspection-ready documentation.

ICSR Case Processing

Intake & triage (email, portal, call center, literature); duplicates and follow-ups management.
Case data entry in Argus/ARISg or sponsor systems; narrative writing and medical assessment.
MedDRA coding of AEs and WHO Drug for medications; seriousness, expectedness, and causality assessment.
Expedited reporting (SUSARs, 15-day/7-day) to authorities/ethics sites via E2B(R3) gateways.
Compliance tracking (due dates, acknowledgments) and reconciliation with clinical databases.

Signal & Risk Management

Signal detection using quantitative methods and medical review; signal validation and prioritization.
Signal evaluation and recommendations; safety communications and labeling change support.
Risk Management Plans (RMPs) and risk minimization measures; effectiveness evaluation.

Aggregate Safety Reporting

Development: DSUR authoring, data lock point coordination, listings/TLFs, and medical interpretation.
Post-marketing: PSUR/PBRER planning and production; benefit–risk assessment and signal summaries.
Periodic safety update schedules, source data reconciliation, and QC/approval workflows.

PV System & Compliance

PV System Master File (PSMF) creation/maintenance; QPPV and deputy support where applicable.
Safety data exchange agreements (SDEAs), vendor oversight, KPIs, and audit programs.
Inspection readiness (EMA, FDA, MHRA): CAPA management, training records, and document control.
Literature surveillance: global and local journals; screening, triage, and case creation.

Deliverables