Pharmacovigilance
TSMR Pharmacovigilance department has a team of qualified Profesionals and experienced QPPV, we provide comprehensive Pharmacovigilance solutions. The team aim to assure the safety of medicines by ensuring reliable and timely exchange of information on drug safety issues, by promoting active reporting of ADRs and enhancing Pharmacovigilance activities across the country. We manage this by having a robust PV system and partnering with healthcare providers at all levels, Pharmaceutical companies and regulatory Authority
- QPPV Services
- Risk management and Signal management
- Establishment and maintenance of the pharmacovigilance system (for receiving handling, evaluations and reporting of ADRs to sustain ADRs reports to the Authority)
- Inspections, audits and compliance (Providing responses to regulatory actions in emerging safety concerns, including variations, urgent safety restrictions and communications to patient and healthcare professionals)
- Record management and Documentation
- Individual case safety report (ICSR) processing and submission
- Preparation and Maintenance of Pharmacovilance Master Plan, PSMF
- Periodic safety Update reports PSURs and Periodic Benefit-risk Evaluation Reports
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Choose TSMR as your designated Focal Firm Responsible for Pharmacovigilance in Tanzania