Pharma Essential Information documentation and capture processes were inconsistent between countries leading to potential ethical and legal issues. Engaged to embed business critical global information capture processes. Chaired pre-SERM (Safety Efficacy Review Meetings); conducted pre-SERM review of all products; identified actions & issues; defined annual & ad-hoc product review cycles; and engaged with clinical & legal experts to secure buy-in. Succeeded in embedding new process & obtaining buy-in from all 22 Pharmas.
Continued as SERM Secretary for a 4-year period, establishing SERM’s reputation as an effective and efficient process with excellent meetings and communications.