Faculty

Nimisha has over twenty years of experience within drug safety and PV having spent a considerable number of years serving as EU QPPV within the Pharmaceutical Industry. Nimisha is the Managing Director of IntuVigilance, a drug safety and PV service provider company serving CROs and Pharma companies, of which The PV Academy forms a subsidiary cohort. Nimisha is dedicated to ethical PV and is associated with several Associations within the Industry such as RQA, PIPA, ACRES, DIA and ISoP. Nimisha is passionate about patient safety and PV and is excited to bring this passion and experience via The PV Academy.

Dr Hegazy has more than 25 years of wealthy experience in Pharmaceutical Industry in different regions and functions (sales, training, medical, marketing and PV).

He was the Head of Global Patient Safety for Africa, Middle East, Turkey, Russia & CIS countries (82 countries) for 7 years in Merck in which he was managing more than 16 subordinates based in 8 different countries.

Reni is the Global PV Operations Manager, with over 14 years of experience within PV in different pharmaceutical companies such as GW Pharmaceuticals, Jazz Pharmaceuticals and Mundipharma.

Harpreet has over 10 years of experience with a proven track record in supporting clients with an array of study needs, from study start-up through to close out.

Henna is an expert in the management of clinical trial safety management and post-marketing PV, with a good understanding of global safety and any other relevant regulations.

Gosia holds a Master Degree in Health Management with a specialisation in Epidemiology from Wageningen University in the Netherlands and additional Post Graduate Diploma in PV from Hertfordshire University in the UK. She began her career at the European Medicines Agency in the Development and Evaluation of Medicines. Gosia comes from Industry, where she plays an integral part in implementing PV processes such as safety variation management and Pharmacovigilance Digital Listening Projects. She is a global expert in Risk Management activities. She also inputs into PVAs, global PSMF and monitors regulatory intelligence in risk management to enable compliance.

Joanne Treacy is an Independent PV Risk Management Consultant with over 18 years Industry Pharmacovigilance experience. Joanne has supported all aspects of PV, from a global perspective, including operational management, safety and benefit risk evaluation and for the last 8 years has had a specific focus on Risk Management strategy and Additional Risk Minimisation Measure/REMS design, implementation and evaluation.  She has worked across multiple therapeutic areas supporting product risk management strategy for filing and throughout the life-cycle including interactions with Health Authorities.  Joanne holds qualifications in public health, health promotion and psychology, and brings methodologies from these areas to ensure risk minimisation programs are patient centric and evidenced based in design and implementation to maximise impact and minimise burden.  For the past 4 years Joanne works as an independent consultant supporting company risk management strategies.

Sue is a former EU QPPV and established expert in pharmacovigilance in Europe, with over 30 years’ pharmaceutical industry experience across a number of organisations including GSK, AstraZeneca and Amgen.

She is a former vice-chair of the efpia Pharmacovigilance Expert Group having served on the group for 10 years and was a member of the ICH E2D R1 working party. Sue holds a BSc (Hons) in Biochemistry and MSc in Immunology and is a Visiting Lecturer at the University of Hertfordshire for the post graduate diploma in pharmacovigilance course.