Samuel Asare Bossman

Responsible for adverse experience case management and aggregate safety report submission management in accordance with Ghana FDA requirements. Oversees safety data filing/archiving, PV compliance, audit/inspection readiness, CAPA planning, and serves as the point of contact for the local Health Authority.

Manages adverse experience case reporting and aggregate safety report submission oversight in line with Ghana FDA requirements. Oversees reconciliation of adverse event reports from other MAHs, PV compliance, audit/inspection readiness with CAPA planning, staff training delivery tracking, and represents the company at external safety meetings.

Implemented and monitored the Quality Management System (QMS) to ensure regulatory and company compliance. Managed SOPs, internal audits, risk assessments, complaints and recalls, deviations/CAPA processes, calibration/maintenance of measuring devices, and coordinated regulatory documentation and renewals with Ghana authorities.

Collected and submitted samples to the QC laboratory for quality analysis and supported laboratory analysis activities. Reviewed registration documents for FDA requirements, managed correspondence/letter coding, and handled customer relations in line with FDA guidelines.

Supported quality control and microbiology work by collecting samples and performing air sampling under GMPs. Conducted drug analyses against pharmacopeial standards and performed microbiological susceptibility testing for raw materials and finished products, with records keeping.

Performed laboratory sample collection for analyses and carried out biochemical and microbiological testing. Maintained records for test results, including biochemical tests (e.g., LFTs, CD4, Widal, MPs, FBC) and microbiological analyses.

Earned a BSc in Biochemistry from the University of Cape Coast (2011–2015).

Completed WASSSCE studies at St. Martins Senior High School (2006–2009).

Completed BECE at St Joseph Catholic School (2003–2006).