BACKGROUND
FOCUS AREAS
Globally recognized leader in pharmacovigilance and risk management.
More than three decades of experience including 19+ years at MHRA and 12+ years as strategic pharmacovigilance advisor.
PV and Risk management
Global PV systems
Recruit, lead, build and develop PV teams
Benefit risk assessment
Signal Management
Authoring and reviewing aggregate reports
GCP and PV Inspection
Mentoring and training
EU/UK QPPVs and regional/local QPPVs in territories requiring PV responsible person
A globally recognized leader in pharmacovigilance and risk management, Shelley brings more than three decades of experience to her role at ELIQUENT Life Sciences. Shelley’s firsthand knowledge of regulatory expectations and her proficiency in navigating complex safety assessments and reporting challenges are invaluable to life science innovators.
Shelley’s extensive professional background includes more than 19 years of service at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). During her tenure, Shelley served in multiple senior positions where she gained extensive knowledge of all European regulatory processes relating to monitoring the safety of licensed medicinal products and ancillary devices.
Shelley’s distinguished MHRA career included a role as the UK representative on the European Medicines Agency’s (EMA) EudraVigilance Expert Working Group. In this capacity, Shelley was instrumental in shaping key pharmacovigilance processes and systems across Europe. Her contributions helped enhance the capabilities of EudraVigilance, the EMA’s system for managing and analyzing information on suspected adverse reactions to medicines which are authorized or being studied in clinical trials in the European Economic Area (EEA).
Prior to joining ELIQUENT, Shelley served for more than 12 years as a strategic pharmacovigilance advisor to clients building and managing pharmacovigilance systems. In this role, Shelley provided pharmacovigilance and risk management support to biotechnology clients across a broad range of therapeutic areas. Her experience includes strategic and technical support in multiple markets from early clinical development to launch readiness. Clients benefited from Shelley’s deep knowledge of global requirements and expert insight on risk management strategies.
In her role at ELIQUENT, Shelley works with clients to ensure compliance with global safety standards, while anticipating changes, and preparing proactive solutions. Her deep understanding of drug safety and risk management protocols directly influences the long-term success of life science innovators.
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EDUCATION:
London School of Hygiene and Tropical Medicine, U. of London
Post graduate certificate (Pharmacovigilance and Pharmacoepidemiology)
Kings College London
Master of Science (MSc) (Biopharmacy)
1991 – 1992
Queen Mary, U. of London
Bachelor of Science (BSc) (Biochemistry)
1988 – 1991
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PV and Risk management expertise in a broad range of therapeutic areas many being first in class.
Specializes in advising clients during their registration journey to product approval on global pharmacovigilance requirements such as risk management strategies, building pharmacovigilance systems to ensure PV compliance in any territory and preparing clients for global regulatory inspections.
Provided risk management strategy and support to many biotech pharmaceutical companies to ensure successful approval in multiple markets.
Provided support to CEOs and CMOs in developing global PV systems to ensure regulatory compliance from early clinical development to launch readiness.
Global PV trainer for organizations.
EU QPPV/UK QPPV and regional/Local QPPV support in territories requiring a PV responsible person – Providing QPPVs, building QPPV offices and their oversight of PV system.
Prepare clients for GCP and PV Inspections.