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Executive – Regulatory Affairs

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

Executive – Quality Assurance (Validation)

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)

Executive – Pharmacovigilance

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

Method of Application

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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.
rnyatangi@ke.aspenpharma.com
cpatel@ke.aspenpharma.com
mmathenge@ke.aspenpharma.com

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