Career Opportunities at Beta Healthcare

Regulatory Affairs duties

• To initiate, monitor and implement the cycle of product registration with various regulatory authorities ie New registrations, request for additional information, variations/amendment, renewals, retentions etc.
• Ensuring compliance with regulations set by the Regulatory Authorities.
• Coordinate timely response to Regulatory Authorities’ queries in liaison with the relevant departments.               
• Liaising, negotiating and maintaining correspondence with regulatory authorities.
• Maintaining an up-to-date register of status of product registrations in the different countries.
• Timely submission of monthly / quarterly / review reports for Regulatory affairs activities.
• Implementation and coordination of Regulatory Affairs Projects.
• Participating in external audits/inspections by various approving authorities.
• Review and approval of product artworks.
• Advise and participate in any quality management system reviews that may be necessary from regulatory guidelines.
• Coordinate product registration / submission of dossiers for affiliate and partnering companies to various territories within the Sub-Saharan Africa (SSA) & French West Africa (FWA) regions.
• Provide Regulatory & 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.

 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

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Quality Assurance duties

• Accountable for overall validation activity
• Preparation and review of site master file and validation master plan
• Preparation of cleaning validation protocols and reports
• Preparation of HVAC qualification / validation protocols and reports
• Designing the hold time study protocols and executing for the products
• Preparation of DQ, IQ, OQ and PQ for manufacturing equipment
• Review and monitoring of validation of process and qualification of equipment/instrument
• Review of instrument and equipment calibration
• Preparation of temperature mapping protocols and reports
• Any other responsibilities given by the Head of the Department / Management.

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 Head – Quality Assurance (SSA)

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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.

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