Coaching/mentoring Medical Reviewers in Pharmacovigilance

In the pharma vertical of a top 5 BPO, clients were raising complaints about the quality, accuracy and promptness of medical review. The levels of category 1 and 2 errors were unacceptable. There were about 25 doctors across 2 clients covering a huge gamut of products. Some of the issues identified were

• Lack of understanding of one’s role
• Misinterpretation of source documents
• Depth of knowledge about company product, trial protocols being handled,
• Lack of understanding of company conventions, MedDRA conventions, causality algorithms
• Need for language coaching so as to improve on narratives and query writing

After individual discussions, followed by group meetings, customised solutions were formulated for each type of problem. We relied more on group discussions, self-reading, presentations, case reviews and cross pollination of ideas and knowledge. Improvement was evident within a quarter, and quality parameters started showing a slight improvement. The process was consistently carried out for about 15 months by which time improvement was substantial and clients expressed satisfaction about the quality of the process. It was time to terminate the mentoring exercise.