Janine Johnson

Background

About Janine Johnson

Janine has more than 25 years experience in pharmaceutical research with a broad range of knowledge from drug development through post-marketing pharmacovigilance monitoring. As a quality assurance and pharmacovigilance professional with Pfizer Inc. she has solid experience in auditing, inspection management, quality system development, compliance management, pharmacovigilence management, and people management. In addition to being an experienced Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) auditor, she has successfully completed the International Organisation for Standardization, ISO 9001 Lead Auditor Certification training. Her compliance experience includes facility, validation, and in-process audits, subcontract monitoring, document review, acting as a compliance advisor and providing compliance training to scientific, technical and quality assurance professionals. As a manager in the Drug Safety Unit she developed expertise in quality system compliance with Health Canada, and US and EU pharmacovigilance (PV) regulations and guidance; maintenance of local PV management system; receipt and processing of adverse reaction reports; documentation management; inspection preparation and management; liaise with business units to advise on PV management with respect to medical information, marketing/sales, patient support programs and clinical research activities; collaborate with global colleagues to develop local processes in compliance with global policy; managed a team of up to 10 safety professionals supporting the local PV operations. Janine was an active member of the Society of Quality Assurance (SQA), a certified GLP auditor (SQA) from 1998 - 2012; and a founding board member of the Canadian regional chapter of the SQA, from 2001 through 2012. Specialties: Quality Assurance, Compliance, GLP, GCP, GVP, Audit, Inspection, Pharmacovigilence, Management