Open to opportunities

Karen Lam

@karenlam

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Pharmacist specializing in pharmacovigilance and regulatory affairs to strengthen medicine and medical device safety.

South Africa

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What I'm looking for

I’m looking for a compliance-focused role where I can drive pharmacovigilance and regulatory excellence—using ISO standards, signal detection, and safety reporting to protect patients while improving quality through audits and clear documentation.

I am a dedicated, detail-oriented pharmacist with experience in pharmacovigilance, regulatory compliance, and adverse event reporting across hospital, retail, and clinical pharmacy. I bring strong analytical, communication, and problem-solving abilities, with a demonstrated commitment to patient safety, quality assurance, and regulations.

In my current medical devices work, I maintain and manage Quality Management systems (ISO 13485), contributing to successful MMS Academy medical writing and multiple recertification/certification audits. I coordinate external audits (e.g., MDSAP, ISO 13485, MDD/MDR), perform signal detection, contribute to benefit-risk assessments, and compile/report safety data (including PSURs) in line with pharmacovigilance expectations in FDA, Health Canada, and EU.

Earlier, as a Regulatory Affairs Pharmacist, I handled PV and aggregate reporting and supported regulatory documentation and technical file requirements. I also served as a Pharmacy Manager, managing staff, ensuring compliance during South African Pharmacy Council and Department of Health inspections, improving corrective actions, and delivering strong pharmacy and inspection outcomes.

Experience

Work history, roles, and key accomplishments

Pharmacy Manager

Linmed

Mar 2020 - May 2022 (2 years 2 months)

Managed a retail/hospital pharmacy team and ensured optimal daily functioning while meeting targets and departmental financial budgets. Optimized stock rotation (avg. 23 days on hand; dormant hospital stock below 5%), dispensed 50 hospital scripts and 30 retail scripts, and achieved an A grade in SAPC inspection plus a 97% Department of Health inspection rating in 2022.

Pharmacy Management Staff Management Stock Management Dispensing Clinical Pharmacy (Ward Rounds)SAPC Compliance Inventory Optimization

Assistant Pharmacy Manager

Linksfield

Sep 2016 - Mar 2020 (3 years 6 months)

Supported operational and regulatory management of pharmacy services, including ensuring compliance during inspections and maintaining accurate internal documentation. Coordinated with clinical stakeholders to resolve medication queries on dosing, duration, and intervals.

Operational Compliance Stock Management SAPC Requirements Record keeping

Retail Pharmacy Manager

Linksfield

Dec 2011 - Aug 2016 (4 years 8 months)

Managed day-to-day retail pharmacy operations, ensuring team performance against pharmacy targets and adherence to SAPC and Department of Health requirements. Produced internal audit reports and implemented corrective actions to improve ongoing regulatory compliance.

Pharmacy Operations Management Staff Management SAPC Compliance Internal Audit Clinical Support (Ward Rounds)

Pharmacist

Linksfield

Jul 2011 - Nov 2011 (4 months)

Worked as a pharmacist supporting daily dispensing operations and ensuring safe, accurate medication supply. Contributed to compliance efforts during inspections through documentation review and corrective action follow-up.

Dispensing SAPC Compliance Stock Rotation Audit Support Pharmacotherapy Problem Solving Patient Counseling Record keeping

Regulatory Affairs Pharmacist

Burnshield (Pty) Ltd

Jan 2003 - Jan 2007 (4 years)

Performed pharmacovigilance and regulatory affairs activities, supporting medicine safety monitoring through adverse event reporting, signal detection, and benefit-risk assessments. Maintained compliance with local and international pharmacovigilance requirements and supported ongoing regulatory documentation and reporting.

Pharmacovigilance Adverse Events Signal Detection Risk Management Regulatory Compliance Medical Device Documentation PSURs EU FDA Health Canada ADR Reporting

Education

Degrees, certifications, and relevant coursework

Sefako Magatho University

Master of Pharmacy, Pharmacy Compliance

Completed a Master’s in Pharmacy focused on regulatory compliance and pharmacovigilance, including medicine safety monitoring and adverse event reporting.