Sue Rees Email & Phone Number

I am an established expert in pharmacovigilance in Europe and former EU QPPV known for my influence at all levels internally and externally with experience of working through industry associations and ICH. I am equally comfortable leading large departments, driving for results as with 1:1 mentoring or sharing my knowledge and expertise with small groups. Throughout my 30 year career I have become known for my skills in presenting at conferences and meetings and leading engaging and effective workshops.

Hatfield, England, United Kingdom

Module leader and MSc project supervisor for PgCert/PgDip/MSc in Pharmacovigilance

Module leader for PV Regulations and Guidance module which runs annually as part of post graduate programme in pharmacovigilance

Cambridge, United Kingdom

EU Qualified Person for Pharmacovigilance with line management of QPPV Office staff and provided governance and oversight to the PV system according to EU legislation. Successfully led several regulatory PV inspections across Europe - providing pragmatic advice and guidance and responding directly to inspectors resulting in no unexpected findings. Established and chaired Safety Reporting in Commercial Programmes Oversight Committee providing governance and advice to commercial function and local safety officers on maintaining compliance in patient support programmes and other commercial initiatives. As a core member of the Executive Safety Committee, Executive Labelling Board and Safety & Labelling Compliance Committee played an active role in decisions regarding assessment and mitigation of risk for all products and processes. Experience of transformation initiatives through sitting on Steering Committee for Partners in Pharmacovigilance Excellence initiative - a strategic end-to-end review of global PV processes and act as sponsor to implementation workstreams to drive efficient compliant process improvement and acting as a core member of Commercial Patient Support Programme transformation initiative.Provided mentorship to more junior staff and worked with Amgen scholars programme.

I played an active role in shaping industry input to the consultation on GVP modules, represented EFPIA at several meetings with EMA and led the working group on safety reporting from PSPs. In 2019 I was appointed vice chair of the PVEG and was appointed EFPIA Topic Lead for the Expert Working Group assigned to the revision of ICH E2D which governs individual case safety reports globally - ICH E2D (R1).

EU QPPV and core member of Global Safety Board, leading implementation of new PV legislation within the organisation.Headed up a team of physicians, scientists and associates responsible for global safety for oncology and GI portfolio, including case processing, aggregate report writing, signal detection and evaluation and risk management planning.Acted as European Regional Safety Officer overseeing a network of local safety officers in European affiliates to ensure safety of Eisai products across the region.

Luton, United Kingdom

• Provided leadership and direction to a large team of scientists and administrative staff responsible for medical information, drug safety and process compliance in the UK marketing company.• Acted as a core member of the Medical & Regulatory Affairs Leadership Team and work to develop and deliver the strategic and operational plans for the Directorate.• Provided operational support for the Medical & Regulatory Affairs Directorate, including co-ordinating internal communications, representing the directorate on the Process, Data & Technology governance committee and the Safety, Health & Environment Committee.• Responsible for driving and developing an enhanced pan-European process for marketing company review and input into Patient Risk Management Plans.• Inputted to strategic direction of Patient Safety across Europe.

Served on the volunteer committee for PIPA (and prior to that AIOPI) helping to drive stratgey and direction for the organisation. Was made an Honorary Fellow in 2011

Over a 17 year tenure rose from an entry level Information Scientist in the UK affiliate answering enquiries and processing adverse event reports to a Director in the Global organisation, accountable for safety evaluation and risk management activities for a group of key assets in the neuroscience therapeutic area in both the pre- and post-marketing arenas, managing a group of scientists and physicians. Undertook an 18-month assignment in Business Strategy and Development leading multi-functional teams to produce 3-year Strategic Plans for products in late stage clinical development, building further understanding of commercial processes and organisation.

Postgraduate Certificate, Learning And Teaching In Higher Education

Msc, Immunology

Bsc (Hons), Biochemistry

A Levels