Highlights:?Regulatory Expertise – Extensive experience in pharmaceutical inspections, drug safety monitoring, and compliance enforcement. ? Public Health Leadership – Skilled in health policy implementation, International Health Regulations (IHR 2005), and post-marketing surveillance. ? Pharmaceutical Quality Assurance – Expertise in drug formulation, quality control, and disposal of expired or counterfeit medications. ? Training & Capacity Building – Conducted training sessions for health professionals, regulatory officials, and pharmaceutical staff. ? Data-Driven Decision Making – Proficient in ABC & VEN analysis, pharmacovigilance reporting, and risk management strategies.

Skills:Inspection of supply chain of pharmaceuticals, Counseling of patient to adhere their treatment, cGMP inspection of pharmaceutical manufacture

Goal:To leverage my expertise in pharmaceutical regulation, public health, and drug safety to enhance healthcare systems, ensure medication quality, and improve patient outcomes through strategic planning, regulatory compliance, and evidence-based decision-making.

Certification:I have different training certificate in and out of country

Honor:I have organizational award from General director of Ethiopia Food and Drug Authority.

Medicine safety and post marketing surveillance expert 06/2023 - current
Ethiopia Food and Drug Authority, Addis Ababa, Addis Ababa Ethiopia
Industry: Health Regulatory
Highly skilled Pharmacovigilance and Regulatory Affairs Specialist with extensive experience in analyzing and evaluating adverse event (AE) data from multiple sources, ensuring compliance with pharmacovigilance regulations, and implementing risk management strategies. Expertise in quality assurance, cGMP inspections, and regulatory system enhancements using ICT solutions. Committed to patient safety, regulatory excellence, and continuous improvement in medicine safety assessment.
Analyze and evaluate data on adverse events (AEs) reported by healthcare professionals, patients, and clinical trials, ensuring timely assessment of seriousness, causality, and risks. Draft and issue acknowledgment letters for reported AEs while maintaining compliance with regulatory guidelines. Prepare comprehensive safety data reports to support risk assessments and regulatory submissions. Contribute to the development and execution of pharmacovigilance plans and risk management strategies for marketed products. Stay updated on pharmacovigilance regulations, scientific literature, and advancements in medicine safety. Provide scientific expertise and guidance on pharmacovigilance and risk mitigation measures. Participate in post-marketing studies to further evaluate the safety profile of medicinal products. Plan and execute annual pharmacovigilance and regulatory strategies to enhance safety monitoring and compliance. Develop and implement quality assurance systems, including regulations, directives, manuals, guidelines, and procedures. Participate in medicine dossier evaluations to assess compliance and product efficacy. Conduct foreign and local cGMP inspections to ensure manufacturing facilities comply with global standards. Prepare documentation to support local manufacturers in producing safe and effective medicines while establishing robust internal quality systems. Facilitate and support regulatory system improvements through ICT integration for better efficiency and compliance.--
Deputy Director of Medicine Inspection Facility Directorate 02/2019 - 06/2023
Ethiopia Food and Drug Authority, Addis Ababa, Addis Ababa Ethiopia
Industry: Health Regulatory Authority
Experienced Regulatory Affairs and Pharmacovigilance Specialist with a strong background in ISO/IEC 17020:2012 compliance, regulatory inspections, and medicine quality assurance. Skilled in planning, coordinating teams, and developing strategies to enhance regulatory systems and ensure medicine and medical device safety. Expertise in Good Manufacturing Practice (GMP) inspections, dossier evaluations, post-market surveillance (PMS), and counterfeit product prevention. Dedicated to strengthening healthcare regulations and ensuring public safety through effective monitoring and evaluation.
Technical Signatory for ISO/IEC 17020:2012, ensuring compliance with international inspection standards. Plan and coordinate annual strategies for the directorate, overseeing regulatory teams and designing new regulatory approaches. Monitor and evaluate weekly, monthly, quarterly, and annual plans and reports for regulatory operations. Develop and implement regulations, directives, manuals, guidelines, and quality assurance procedures to strengthen regulatory frameworks. Review and approve inspection reports, issuing new and renewed Certificates of Compliance (COC) for facilities that meet regulatory criteria. Evaluate medical waste disposal reports and issue certifications to ensure environmental and health safety compliance. Assess the presence of internal quality management systems in medicine and medical device manufacturers through inspection reports. Participate in medicine dossier evaluations to assess product quality, efficacy, and regulatory compliance. Conduct foreign and local cGMP inspections to ensure manufacturers adhere to quality standards. Prepare and review documentation for local manufacturers, ensuring the production of safe and effective medicines while establishing robust internal quality systems. Facilitate and integrate ICT solutions to improve regulatory processes and compliance tracking. Enforce administrative measures based on inspection findings, ensuring adherence to legal and regulatory requirements. Prevent the distribution of counterfeit products, safeguarding public health. Lead pre- and post-market surveillance (PMS) activities on local and imported products, taking necessary actions against substandard medicines. Supervise and inspect medicine and medical device importers and distributors, ensuring compliance with regulatory requirements.--
Head, EFMHACA Branch Offices Coordination office 09/2014 - 02/2019
Ethiopia Food and Drug Authority, Addis Ababa, Addis Ababa Ethiopia
Industry: Health Regulatory Authority
Dedicated Regulatory Affairs and Public Health Specialist with extensive experience in pharmaceutical regulatory compliance. Expertise in planning, monitoring, and evaluating regulatory activities across branch offices and border control points. Strong background in post-marketing surveillance, dossier evaluations, cGMP inspections, pharmaceutical quality control, and public health emergency preparedness. Adept at training, capacity building, and policy implementation to strengthen regulatory frameworks and ensure medicine and medical device safety
• Annual Strategic Planning: Develop and oversee the execution of annual plans for the organization, ensuring alignment with regulatory objectives. • Monitoring & Evaluation: Track and assess weekly, monthly, quarterly, and annual reports from branch offices and entry/exit ports to ensure regulatory compliance. • Health Screening & Surveillance: • Daily reporting of Ebola-screened international passengers at all entry and exit points for national focal authorities. • Monitor and support the implementation of International Health Regulations (IHR 2005) at border points. • Regulatory Compliance & Inspections: • Participate in medicine and medical device dossier evaluations for regulatory approvals. • Conduct foreign cGMP inspections to ensure manufacturing compliance with global standards. • Oversee pharmaceutical product monitoring at branches and border points. • Support and monitor branch pharmaceutical quality control laboratories to maintain high testing standards. • Participate in post-marketing surveillance (PMS) of drugs to assess product safety and quality. • Training & Capacity Building: • Provide health regulation training to entry/exit port officials and branch office staff. • Lead IHR/core capacity building assessments for border health security improvements. • Organize and deliver capacity-building programs for branch and entry/exit port personnel. • Operational & Logistical Support: • Ensure entry/exit ports and branch offices are equipped with necessary logistics for regulatory functions. • Solve operational challenges and implement solutions for branch offices and border control points. • Foster collaboration between branch offices and regional health regulatory bodies to strengthen regulatory frameworks. • Strategic Leadership & Policy Implementation: • Develop new health regulatory strategies and oversee their implementation. • Represent 07 branch offices in management committee meetings, advocating for regulatory improvements and operational support--
Director of FMHACA N/W Branch Office 12/2011 - 9/2014
Ethiopia Food and Drug Authority, Addis Ababa, Addis Ababa Ethiopia
Industry: Health Regulatory Authority
Experienced Regulatory Affairs and Public Health Specialist with expertise in food, medicine, and healthcare regulation at branch offices and ports of entry/exit. Skilled in strategic planning, regulatory compliance, and implementation of International Health Regulations (IHR 2005). Strong background in capacity building, training, and leadership in public health and pharmaceutical safety
Annual Strategic Planning: Develop and oversee the execution of annual regulatory plans for the organization. Regulatory Oversight: Lead and coordinate branch offices and two ports of entry/exit in enforcing food, medicine, and healthcare regulations. IHR 2005 Compliance: Monitor and support the implementation of International Health Regulations (IHR 2005) at designated ports of entry/exit. Training & Capacity Building: Provide training programs for port officials on health regulations and compliance. Strengthen institutional capacity to ensure adherence to international and national regulatory standards--
Health and Health Related institutions and Products Quality inspector 03/2010 - 10/2011
Ethiopia Food and Drug Authority, Bahir Dar , Amhara Ethiopia
Industry: Health Regulatory Authority
Experienced Regulatory Affairs and Pharmaceutical Inspector with expertise in drug safety, compliance and enforcement. Skilled in pharmaceutical inspections, narcotic and psychotropic substance control, adverse drug reaction (ADR) monitoring and post-marketing surveillance. Proven ability to develop strategic regulatory plans, conduct risk-based inspections, and ensure compliance with national and international pharmaceutical regulations. Committed to protecting public health by preventing the distribution of counterfeit, adulterated, and expired medications
• Regulatory Planning & Reporting: • Develop and implement annual regulatory plans for the organization. • Prepare and submit detailed weekly, monthly, and quarterly reports on inspection findings and regulatory actions. • Pharmaceutical Inspection & Compliance: • Inspect pharmaceutical wholesalers, distributors, and specialized health institutions to ensure compliance with regulations. • Conduct pre-licensing inspections of premises as a prerequisite for issuing Certificates of Competence (COC). • Inspect the distribution, prescribing, dispensing, use, and record-keeping of narcotic drugs, psychotropic substances, and precursor chemicals. • Inspect pharmaceutical products at ports of entry and exit to prevent unauthorized or substandard drugs from entering the market. • Detect and quarantine adulterated, counterfeit, spoiled, contaminated, or potentially dangerous drugs until laboratory testing confirms their safety. • Oversee the proper disposal of expired or damaged drugs to prevent environmental and health hazards. • Drug Safety & Post-Marketing Surveillance: • Participate in adverse drug reaction (ADR) monitoring and reporting to ensure patient safety. • Conduct post-marketing surveillance (PMS) of pharmaceutical products to assess ongoing safety and efficacy.--
Drug inspection and competency certifying expert 02/2008 - 03/2010
Ethiopia Food and Drug Authority, Bahir Dar , Amhara Ethiopia
Industry: Health Regulatory Authority
Experienced Pharmaceutical Inspector and Regulatory Affairs Specialist with a strong background in drug safety, compliance, and enforcement. Skilled in inspecting pharmaceutical manufacturers, importers, wholesalers, distributors, and healthcare institutions to ensure compliance with national and international regulations. Expertise in narcotic and psychotropic substance control, counterfeit drug regulation, post-marketing surveillance, and pharmaceutical waste disposal. Dedicated to strengthening regulatory frameworks and public health protection through policy development and enforcement.
Pharmaceutical & Healthcare Institution Inspections: Conduct competency certificate inspections for drug manufacturers, importers, distributors, wholesalers, retail outlets, and healthcare institutions to ensure regulatory compliance. Inspect narcotic drugs, psychotropic substances, and precursor chemical manufacturers, importers, wholesalers, retailers, and healthcare institutions to verify legal compliance. Drug Safety & Market Regulation: Inspect pharmaceutical products at entry and exit ports to prevent illegal or substandard drugs from entering the market. Regulate and take action against non-registered, counterfeit, and illegal drugs found in circulation. Ensure the safe and legal disposal of pharmaceutical waste according to regulatory requirements. Post-Marketing Surveillance & Policy Development: Participate in post-marketing surveillance (PMS) of drugs to assess ongoing safety, quality, and efficacy. Contribute to the preparation and development of regulatory guidelines to enhance pharmaceutical and health product safety.--
Junior Drugist 10/2004 - 01/2008
St.Peter’s TB Specialized Hospital /Minstry of Health, Bahir Dar , Amhara Ethiopia
Industry: Hospital
Highly skilled Pharmacist and Regulatory Specialist with expertise in pharmaceutical forecasting, procurement, budget monitoring, and regulatory compliance. Experienced in drug safety evaluation, prescription review, controlled substance management, and medication counseling. Strong background in ABC and VEN analysis, pharmaceutical inventory management, and adherence to national and international health regulations. Dedicated to ensuring safe, effective, and high-quality pharmaceutical services in both regulatory and clinical settings.
Pharmaceutical Procurement & Budgeting: Forecast and procure pharmaceuticals to ensure adequate supply. Monitor and manage pharmaceutical budget utilization for cost-effective operations. Drug Safety & Quality Assurance: Assess the identity, strength, and purity of medications to ensure quality standards. Perform ABC and VEN analysis for effective inventory control and prioritization. Dispose of damaged and expired drugs following regulatory guidelines. Clinical & Regulatory Pharmacy Services: Review prescriptions for accuracy, appropriate dosage, and ingredient suitability. Provide expert counseling on drug interactions, side effects, dosage, and proper medication storage. Maintain records of pharmacy files, patient profiles, controlled substances, narcotics, and radioactive materials to ensure compliance with health regulations. Oversee dispensing and counseling services at ART (Antiretroviral Therapy) pharmacies to support patient adherence and safety.--
Junior Druggist 07/2004 - 10/2004
Alefa woreda Heath office/North Gondar, Shawura , Amhara Ethiopia
Industry: Health Center
Dedicated Pharmacist and Pharmaceutical Regulatory Specialist with expertise in pharmaceutical procurement, budget monitoring, drug safety assessment, and regulatory compliance. Skilled in prescription review, controlled substance management, medication counseling, and inventory analysis (ABC & VEN). Committed to ensuring safe, effective, and high-quality pharmaceutical services while maintaining adherence to national and international health regulations.
Pharmaceutical Procurement & Budgeting: Forecast and procure pharmaceuticals to maintain adequate stock levels. Monitor and manage pharmaceutical budget utilization to optimize cost efficiency. Drug Safety & Quality Assurance: Assess the identity, strength, and purity of medications to ensure compliance with quality standards. Perform ABC and VEN analysis for effective inventory and resource allocation. Dispose of damaged and expired drugs following regulatory guidelines. Clinical & Regulatory Pharmacy Services: Review prescriptions to ensure accuracy, appropriate dosage, and ingredient suitability. Provide expert counseling on drug interactions, side effects, dosage, and medication storage. Maintain records of pharmacy files, patient profiles, controlled substances, narcotics, poisons, and radioactive materials for regulatory compliance. Oversee dispensing and patient counseling at ART (Antiretroviral Therapy) pharmacies to support adherence and treatment success.--

Gondar University 10/2007 - 06/2011
Gondar, Amhara, Ethiopia
Degree: Bachelor's Degree
Major:Pharmacy
Qualified Bachelor of Pharmacy (BPharm) graduate with a strong foundation in pharmaceutical sciences, drug safety, pharmacology, and patient-centered care. Skilled in medication dispensing, prescription review, pharmaceutical calculations, and regulatory compliance. Experienced in drug formulation, quality control, and inventory management to ensure the safe and effective use of medicines. Passionate about pharmacovigilance, clinical pharmacy, and optimizing healthcare through evidence-based medication practices

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