Pharmacovigilance and Drug Safety

Drug safety expertise

THESYL provides pharmacovigilance and drug safety services designed for the African regulatory environment from LPPV appointment and local compliance to regional and pan-African post-marketing surveillance programmes. Our services apply ICH-standard processes within frameworks shaped by national and regional regulatory authorities.

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Clinical PV

Safety monitoring for investigational products during clinical trials including SAEs, SUSARs, and clinical safety plans.

Post-Marketing PV

Continuous surveillance for approved products with ICSRs, signal detection, PSURs, and RMP support.

Local to Regional to Pan-African

Scalable PV coverage that starts locally and expands with your product portfolio.

THESYL pharmacovigilance services cover both phases of the product lifecycle, clinical development and post-marketing. The same rigorous processes are applied in each phase with their specific reporting obligations.

Pharmacovigilance compliance is actively enforced

Regulatory scrutiny is increasing during renewals, variations, and inspections. Many MAHs still lack a compliant local pharmacovigilance person in-country.

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 and Representation
Pharmacovigilance system setup and management
PSMF management
Regulatory authority liaison and communication
Regulatory intelligence and compliance monitoring
Partner management and PV training
Audit and inspection readiness

Countries covered

National Regulatory Authority Uganda NDA Kenya PPB Tanzania TMDA Burundi ABREMA DRC ACOREP

Our post-marketing services involve continuous collection, assessment, and analysis of adverse event data from healthcare professionals, patients, and literature with alignment to national and regional requirements.

Safety database management
ICSR management and reporting
MedDRA and WHO Drug coding
Case narrative writing
Literature review and 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

  1. 1

    Case Intake and Receipt

    Mailbox and system intake, acknowledgment, and source registration.

  2. 2

    Data Verification and Triage

    Validity checks, duplicate search, triage, and case registration.

  3. 3

    Data Entry and Case Processing

    Coding, causality and expectedness assessment, and narrative drafting.

  4. 4

    Quality Review

    Validity, coding consistency, listedness, seriousness, and data accuracy checks.

  5. 5

    Medical Review

    Medical confirmation of seriousness and causality, with company clinical comment.

  6. 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

Ready to discuss your pharmacovigilance needs?

Whether you need an LPPV appointment, end-to-end post-marketing pharmacovigilance, or clinical safety support for a trial at an African site, we can scope a solution aligned to your obligations and timeline.

Request a PV consultation