The Managing Director of Wise Pharmacovigilance and Risk Management Ltd is Lesley Wise.
Lesley is an established pharmacovigilance professional with more than 16 years of experience in the field of pharmacovigilance; both in medicines regulation (as head of the risk management and pharmacoepidemiology group at the MHRA), and also in the pharmaceutical industry as vice-president and global head of the Risk Management Centre of Excellence and Pharmacoepidemiology.
She is also an honorary lecturer in Pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, and an associate editor of Therapeutic Advances in Drug Safety.
Until July 2016 she was vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology at Takeda Pharmaceutical Company. Here she worked closely with Pharmacovigilance, Regulatory and Medical Affairs colleagues to ensure a companywide integrated approach to Benefit-Risk Management and to maintain compliance with regulatory requirements.
This role included the leadership of the Pharmacoepidemiology team, the formation of signal processes, risk management processes, and benefit-risk assessments as well as external facing research initiatives.
As part of this role she was required to liaise regularly with external regulators, such as meetings with PRAC, CHMP and FDA (including presenting at an FDA Advisory Committee).
Lesley’s experience as a regulator and as a senior executive in industry provides her with a unique ability to guide benefit-risk assessments and pharmacovigilance processes to successful conclusions.