PURPOSE OF ROLE :
This role is accountable for all activities related to ensuring that accurate, and legally required, communication of safety and adverse event information for all drug products distributed. In addition the role is responsible for defining and coordinating the implementation of the Good Distribution Practice.
Responsibilities:
Regulatory
Preparing, reviewing and adhering to Kenyan pharmaceutical regulation and local guidelines;
Ensuring premises have the proper licenses and appropriate documentation for operations of the pharmaceutical business;
In coordination with the suppliers and other teams, work on the evaluation & preparation of documentation and dossier for initial registration, and follow up for renewal registration of pharmaceutical products;
Coordinate with the supplier/manufacturer regarding product requirements and other regulatory matters;
Manage the handling of Licit Narcotics products, preparation, importation, supervise warehousing and sales;
Also submit Licit Narcotics reports to the PPB;
Directly responsible for the submission and follow up of permits with the PPB for importation of pharmaceutical products.
Pharmacovigilance
Manage all aspects of pharmacovigilance activity, in partnership and with guidance from supplier;
Write and submit pharmacovigilance reports from suppliers to the PPB;
Investigate any pharmacovigilance activities relating to products sold.
Good Distribution Practices
Conduct audit of suppliers and assessment of the pharmaceutical risk linked to operations;
Implementing standard operating procedures (SOPs), train staff and coordinate with the suppliers in case of adverse events;
For selected quality systems, provide technical knowledge and remediate selected quality gaps as a result of new or revised policies, procedures and guidelines and ensure that practices in the relevant systems are in alignment with SOPs and guidelines;
Take responsibility for conformity to Good Distribution Practice (GDP) standards in Warehouse & Operations.
General
Ensure the pharmaceutical operations are in line with the organization’s requirements for quality, legal stipulations and environmental policies;
Develop Key Performance Indicators (KPIs) for the pharmaceutical operations and submit regular reports linked to action plans and corrective actions;
Responsible for developing, reviewing, enhancing and implementing policies and procedures related to distribution operations;
Coordinate with the local clearing agent the process of stock importation and clearance;
Coordinate with local shipping agents the process of stock exportation to EA countries.
Qualifications
Degree in Pharmacy;
Registered Pharmacist;
3 – 5 years of experience;
Experience in pharmacovigilance, quality assurance and regulatory affairs.
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