Overview of Pharmacovigilance

Pharmacovigilance (PV), often referred to as drug safety, is a critical function within life sciences companies. It encompasses the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Our expert Pharmacovigilance Services are designed to ensure the safety and efficacy of medicinal products throughout their lifecycle, particularly within the dynamic African regulatory landscape.

Our Comprehensive Pharmacovigilance Offerings

ECP provides a full spectrum of pharmacovigilance services, tailored to meet the unique needs of our clients and the stringent requirements of African Medicines Regulatory Authorities (AMRAs). Our services include:

• Literature Monitoring: Proactive surveillance of scientific literature for potential safety signals.
• Individual Case Safety Report (ICSR) Management: Efficient collection, processing, and reporting of individual adverse event cases.
• Aggregate Reporting: Preparation and submission of periodic safety reports such as PSURs, PBRERs, and DSURs.
• Risk Management: Development and implementation of robust risk management plans to minimize drug-related risks.
• Signal Management: Detection, assessment, and management of new or changing safety signals.
• Audit Support and Training: Preparation for regulatory inspections and comprehensive training programs for PV personnel.
• Quality Assurance and Analysis: Ensuring the highest quality in all PV activities and data analysis.
• Qualified Person for Pharmacovigilance (QPPV) Services: Provision of experienced QPPVs to oversee your PV system.
• Safety Regulatory Intelligence: Keeping you informed about evolving PV regulations across Africa.
• Database Services & Technology Solutions: Expertise in managing various pharmacovigilance safety databases.

Why Partner with ECP for Pharmacovigilance?

Choosing ECP as your pharmacovigilance partner offers significant advantages. We provide a single point of contact for end-to-end drug safety services, alleviating the burden of unpredictable report volumes and allowing your internal resources to focus on strategic initiatives. Our team possesses in-depth safety knowledge, integrated with the necessary IT capabilities, ensuring timely delivery and the highest quality in pharmacovigilance and drug safety. We have hands-on experience with standard and customized PV databases and expertise in setting up compliant pharmacovigilance systems and processes.

Our commitment is to help you navigate the complexities of pharmacovigilance in Africa, ensuring compliance, patient safety, and the continued availability of effective medicines.