Pharmacovigilance duties

• Establishing, assessing and implementing risk management systems and evaluating the effectiveness of risk minimization.
• Collection, processing, management, quality control, follow-up for missing information, coding, classification, duplicate detection, evaluation and timely electronic transmission of individual case safety reports (ICSRs).
• Signal management including literature reviews.
• Scheduling, preparation (including data evaluation and quality control), submission and assessment of periodic safety update reports.
• Meeting commitments and responding to requests from competent authorities, including provision of correct and complete information.
• Interaction between the pharmacovigilance and product quality defect systems.
• Communication of safety concerns to competent regulatory authorities, in particular notifying changes to the risk-benefit balance of medicinal products.
• Communicating to patients and healthcare professionals about changes to the risk-benefit balance of products for the aim of safe and effective use of medicinal products.
• Keeping product information up-to-date with the current scientific knowledge, including the conclusions of the assessment and recommendations from the applicable competent authority.
• Implementation of variations to marketing authorizations for safety reasons according to the urgency required.
• Maintenance of the PSMF.
• Provide Pharmacovigilance Intelligence in various countries within the SSA, FWA, EA & AWA regions, to Aspen Group and internally as applicable.
• Any other duties as allocated by Management.

Requirements

Desired Profile

• Education: Bachelor of Pharmacy (Registered with pharmacy and Poisons board, Kenya)
• Experience: +2 years
• Good knowledge of Microsoft office and databases

Reporting Line

• To Manager-Pharmacovigilance and Regulatory Affairs