Emily Mochama
Qualified Person for Pharmacovigilance @ Sphinx Pharmaceuticals ltd
About
As a Certified Regulatory Affairs Specialist at Sphinx Pharmaceuticals, I contribute to dossier preparation for product registration and re-registration, manage product variations, and facilitate electronic submissions to regulatory authorities. My role involves close collaboration with internal teams, regulatory consultants, and the Pharmacy and Poisons Board to ensure compliance and streamline pharmaceutical processes. Holding a Bachelor of Pharmacy from the University of Nairobi, I am advancing my expertise through a Master's degree in One Health at the University of Edinburgh. This educational foundation, combined with skills in systems thinking and negotiation, supports my commitment to enhancing healthcare safety and efficacy through regulatory excellence and effective collaboration.
Kenya
Nairobi County
Human Resources
Dossier review, Systems Thinking, Negotiation, Supervising and Delegating, Conflict Management, Effective Communication, Program and Project Management, Strategic Planning, Capacity Building, Time Management, Decision-Making, Financial Management, Risk Assessment, Application for GMP certificate, Application for variations, Initiation and tracking of product recalls, Pharmacovigilance, Product registration renewal, Bioequivalence Studies and Good Clinical Practices, Cross-team Collaboration
Experience

Qualified Person for Pharmacovigilance
Nairobi County, Kenya
Establishment and maintenance of Pharmacovigilance System. Preparation and maintenance of Pharmacovigilance System Master File. Collection, processing and reporting of ICSRs Preparation and submission of Periodic Safety Update Reports (PSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs). Preparation and Submission of Risk Management Plans (RMPs) and implementation of risk mitigation measures. Causality Assessment

Certified Regulatory Affairs Specialist
Nairobi County, Kenya
I excelled in ensuring regulatory compliance and lifecycle management for a portfolio of pharmaceutical products. • Achieved 100% adherence to submission deadlines, facilitating continuous market access. • Conducted thorough analyses of PSURs and QIS, enhancing product safety profiles. • Collaborated closely with Legal and Quality teams to navigate complex regulatory investigations.

Community Pharmacy and Primary Healthcare Intern
Flame Tree Pharmacy and Embakasi Health Centre
Nairobi County, Kenya
I gained valuable experience as a Pharmacist Intern, focusing on precision in pharmacy operations and patient care. • Maintained meticulous documentation of pharmacy operations, achieving 100% accuracy in inventory management. • Educated patients on medication adherence, enhancing their understanding of chronic disease management. • Developed strong skills in attention to detail and effective communication in a healthcare setting.

Hospital Pharmacy Intern
Nairobi County, Kenya
I had the opportunity to enhance my clinical and operational skills as a Pharmacist Intern at Kenyatta National Hospital. • Actively contributed in a Point Prevalence Survey, analyzing data from over 300 patient records. • Served as the Pharmacist Interns Representative, addressing complex issues and improving peer communication. • Developed essential therapeutic knowledge through direct medical interventions during ward rounds.

Industrial Pharmacy Apprentice
Nairobi County, Kenya
I played a pivotal role in enhancing pharmaceutical quality and compliance at Sphinx Pharmaceuticals Ltd. • Authored the quality section for the Tricoff Expectorant CTD dossier, demonstrating strong technical expertise. • Analyzed PQR data for over 25 formulations, leading to the identification of eight adverse trends. • Conducted GMP trainings for internal teams, aligning with the need for deep medical and compliance understanding.

Pharmacist Intern
Martpharm Pharmacy
South C Nairobi
• Facilitated patient education on medication use and health management to enhance understanding and adherence. • Reviewed prescriptions and dispensed over-the-counter medicines, ensuring 100% accuracy and safety in medication delivery. • Managed inventory and supply chain operations to maintain optimal stock levels and streamline pharmacy processes.

Relationship officer- Operations
Kenya
• Developed and nurtured new client relationships by leveraging extensive banking product knowledge. • Ensured high ethical standards and sound banking operations to support business success. • Proactively sourced new business through internal and external referral networks. • Delivered exceptional customer service, enhancing client retention and satisfaction.

Relationship officer- Operations
Kenya
I successfully established and maintained strong client relationships while ensuring ethical banking practices. • Developed new business opportunities through proactive networking and referrals, enhancing client engagement. • Participated in client events to promote products and gather valuable customer feedback for service improvement. • Ensured high customer satisfaction by providing reliable support and updates on banking products.
Emily Mochama's Contact Information
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