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Fidelma Reid, B.Sc, MLIS, M. Pharm. Med.
Senior Director, Vigilance Operations
As a Senior Director, Fidelma is responsible for:
- Project management and support on pharmacovigilance pre-authorization projects (from phase 1 to 3 worldwide clinical trials) and post-authorization projects (both for European centralized and national approved products) to set-up and maintain pharmacovigilance systems in line with applicable regulations.
- Acting as EU QPPV
- Support the Pharmacovigilance group coordination, resources, training, business development, knowledge management, and quality assurance activities
Fidelma brings to the role more than 25 years of experience in the global pharmaceutical industry. During that time, Fidelma has developed extensive knowledge of GVP/GCP/ICH guidelines and FDA & EMA regulations, and in addition to competencies in stakeholder management and a commitment to compliance and continuous improvement.
Her extensive operational experience includes 14 years spent in Quintiles Pharmacovigilance, where she was EU QPPV for 4 pharma companies since 2008.
During another period as EU QPPV for Aspen Pharma (from Aug 2012 – March 2014), she led the pharmacovigilance department through 3 regulatory inspections and 2 partner audits in a 12-month period and drove the creation of SOPs to reflect the new European PV (GVP) legislation.
Other positions in Roche, Deloitte and Novartis have given Fidelma solid experience in the safety of both marketed and development compounds and honed her interpersonal and communications skills, allowing her to be confident in coordinating with senior staff in other functions.
Fidelma is based in Dublin, Ireland.