Clinical PV
Safety monitoring for investigational products during clinical trials including SAEs, SUSARs, and clinical safety plans.
Pharmacovigilance compliance is actively enforced
Pharmacovigilance obligations across African markets are subject to increasing regulatory scrutiny — during registration renewals, variation assessments, and inspections. The majority of MAHs with products registered in African markets do not yet have a compliant local pharmacovigilance person (LPPV) in place. This is a growing regulatory liability.
The appointment of a Qualified Person for Pharmacovigilance (QPPV) is mandatory in the EU and increasingly required across Africa. At the country level, a Local Pharmacovigilance Person (LPPV) is required to meet national regulatory authority and other African NRA obligations — providing an in-country contact with genuine PV competence, direct regulatory authority communication capability, and local ICSR collection oversight.
THESYL provides QPPV and LPPV appointment and representation services for MAHs operating across Africa, combining direct regulatory authority experience with ICH-standard pharmacovigilance competence.
QPPV and LPPV Appointment & Representation
Pharmacovigilance system setup & management
Pharmacovigilance System Master File (PSMF)
Regulatory authority liaison & communication
Regulatory intelligence & compliance monitoring
Partner management
PV Training & Support
Audit & inspection readiness
Our post-marketing pharmacovigilance services involve the continuous collection, assessment, and analysis of adverse event data from healthcare professionals, patients, and literature. We ensure compliance with post-marketing surveillance requirements and global regulatory standards while safeguarding public health by identifying, assessing, and mitigating potential safety risks associated with registered products.
Safety database management
ICSR management & reporting
MedDRA & WHO Drug coding
Case narrative writing
Literature review & monitoring
National PV database monitoring
ICSR case collection and processing sits at the core of pharmacovigilance in clinical and post-marketing contexts. We prioritize ICH E2B compliance and country-specific reporting requirements throughout.
ICSR Case Processing - Six-Step Workflow
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1
Case Intake and Receipt
Mailbox and system intake, acknowledgment, and source registration.
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2
Data Verification and Triage
Validity checks, duplicate search, triage, and case registration.
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3
Data Entry and Case Processing
Coding, causality and expectedness assessment, and narrative drafting.
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4
Quality Review
Validity, coding consistency, listedness, seriousness, and data accuracy checks.
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5
Medical Review
Medical confirmation of seriousness and causality, with company clinical comment.
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6
Submission
Submission of ICSRs to regulatory authorities within required timelines.
Clinical Context
- SAE and SUSAR management
- Expedited reporting to regulatory authority and ethics committee
- Development Safety Update Reports
- Clinical safety management planning
Post-Marketing Context
- ICSRs from healthcare providers and patients
- Reporting to competent authorities
- E2B(R3) formatted submissions
- Follow-up and case closure
Our signal management services combine expert analysis with systematic review of adverse events, literature, and real-world evidence to detect and prioritize emerging risks across the product lifecycle.
Automated and manual signal detection
National PV database monitoring
Signal validation and prioritisation
Clinical and regulatory impact assessment
Real-world evidence integration
Scientific literature surveillance
We prepare and submit PSURs, PBRERs, DSURs, and related periodic reports in compliance with ICH E2C, ICH E2E, and local authority requirements across African markets.
Periodic Safety Update Reports
Periodic Benefit-Risk Evaluation Reports
Development Safety Update Reports
Periodic Adverse Drug Experience Reports
national regulatory authority country-specific reports
African NRA country-specific reports
THESYL delivers end-to-end risk management support including RMP authoring, minimization strategy design, implementation oversight, and ongoing effectiveness evaluation.
RMP development and authoring
Risk minimisation strategy design
RMP implementation oversight
Ongoing RMP evaluation and updates
national regulatory authority RMP submission
REMS programme coordination
Clinical trial context
Our clinical PV services support sponsors and investigators in monitoring benefit-risk balance throughout development and align with ICH E2A, ICH E6(R3), and country-specific requirements.
Safety database service
ICSR management and reporting
MedDRA and WHO Drug coding
SAE and SUSAR management
Case narrative writing
Clinical safety management planning
Safety report preparation and submission
Development Safety Update Reports