Beta Healthcare international ltd, a member of the Aspen Group of Companies, is a leading pharmaceutical manufacturer and distribution company in sub-Saharan Africa, based in Nairobi, Kenya.
We are seeking to recruit qualified individuals for the above position.
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
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.Interested candidates must send their application letters, updated CV (including three referees), copies of academic certificates and daytime telephone contact to the undersigned through email below by 15th Dec, 2023.
To Manager-Pharmacovigilance and Regulatory Affairs
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.Interested candidates must send their application letters, updated CV (including three referees), copies of academic certificates and daytime telephone contact to the undersigned through email below by 15th Dec, 2023.
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