Anne Lucuta has over 20 years’ experience in the pharmacovigilance industry across both clinical and post-marketing sectors, having previously held senior positions in both the Contract Research Organisation setting and global pharma.

During her career, Anne has worked across a wide range of pharmacovigilance activities including aggregate reports, risk management, signal detection, literature review, process development and improvement, regulatory authority interactions, regulatory intelligence and mentoring and training. Prior to her pharmacovigilance positions, she worked in clinical trial data management.

In the past five years, Anne has focused on acting as a pharmacovigilance consultant across a range of therapeutic areas, supporting clients through various projects including gap analysis, pharmacovigilance system set-up, preparation for marketing authorisation application and fulfilment of post-marketing pharmacovigilance responsibilities.

Anne possesses expert scientific writing skills, with a strong background in data analysis and evaluation and a wealth of experience in the preparation of pre- and post-marketing aggregate reports and risk management plans.

Anne is a graduate of University College Dublin having been awarded a BSc in Pharmacology and Microbiology and a PhD in Pharmacology.

Managing Partner & Co-Founder

Carly Gould has over 20 years' experience in pharmacovigilance both in clinical and post-marketing arenas.

Key areas of focus include establishing PV systems, providing clients with strategic PV advice, product acquisitions and partner management, QMS development, cross departmental process analysis, optimization and implementation.

Prior to founding Signal Pharma Experts, Carly was Director of Client Management and QPPV in Diamond PV Services, which went on to become ProPharma Group, dQPPV and Head of Medical Services at Amdipharm Plc and held senior positions at Generics UK with a global portfolio of over 400 generic products.

Carly was awarded a BSc (Honors) degree in Human Physiology at the University of East London.

Managing Partner & Co-Founder

Catherine Kenny has over 15 years’ experience in the pharmacovigilance industry across both clinical and post-marketing sectors.  In the past 5 years she has focused on acting as an EU QPPV and consultant across a range of therapeutic areas. As a consultant, Catherine is particularly interested in conducting gap analyses and ensuring that companies have the infrastructure and foundations in place to navigate the PV landscape in a compliant fashion.

During her time working in industry, Catherine has managed teams and developed processes across a range of PV activities, ensuring that the systems and mechanisms in place are robust and fit for purpose.

Catherine has spent several years acting as a contract EU QPPV and consultant and has implemented and re-designed processes to fit the needs of the client. Ensuring that the PV system is supported by a robust Quality Management System and cross-departmental infrastructure is part of the holistic approach to process development.

Over her career, Catherine has been involved in and managed multiple audits and regulatory inspections (FDA, EMA, MHRA).  CAPA remediation and management is a keen area of interest.

Throughout her career, Catherine has been involved in several company mergers and acquisitions, along with the acquisition/ divestment of multiple products and is keenly interested in guiding companies through these challenging times.

Fionnuala has over 14 years’ experience in the pharmacovigilance operations and strategy, across both clinical safety and post-market pharmacovigilance sectors.

In the past five years, Finn has been part of Senior management teams focused on managing Clients who require outsourcing of pharmacovigilance services and ensuring that they receive the best support across all operational teams.

During her time within industry, Finn developed key processes across post marketing and clinical teams providing Operational support to Clients and managing the operational teams. Ensuring all teams are compliant with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations.

Alongside this, she has led Client audits and Inspection sessions, managed projects, functioned as a deputy QPPV and UK National Contact Person for PV. Finn also has experience managing Quality Management System (QMS) activities, training and providing oversight to Senior Management.

Finn has a focus on staff and vendor management and is our Head of Staff and Client Relations at Signal, leading and supporting the team to provide the best services possible to our diverse range of Clients.

Degree in Criminology and Psychology from the University of Brighton.

Hannah has over 7 years’ experience in pharmacovigilance operations and post-market pharmacovigilance.

Over the course of her career, Hannah has worked with several pharmacovigilance service providers, where she has led operational teams, managed client relationships, and ensured the smooth delivery of pharmacovigilance services tailored to client needs. 

During her time in the industry, Hannah has taken responsibility for the coordination and maintenance of Pharmacovigilance System Master Files (PSMFs) for multiple clients, ensuring compliance with Good Pharmacovigilance Practice (GVP) guidelines. She has provided strategic guidance during changes to client product portfolios and supported the integration of pharmacovigilance considerations into broader business decisions.

In addition, Hannah has participated in audits and regulatory inspections, authored and maintained standard operating procedures, and played a key role in ensuring continuous quality and compliance within pharmacovigilance systems.

Degree in Biology and Animal Behaviour from the University of Exeter. 

Priya has over 15 years’ experience in the pharmaceutical industry, across both clinical safety and post-market pharmacovigilance sectors. In the past five years, she has focused on utilising her prior pharmacovigilance operational experiences to lead quality assurance activities across the Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GpVP), whilst also working on synergistic projects across GxP. Quality assurance activities also included involvement in, leading in and undertaking audit and inspection responsibilities.

During her time working in industry, Priya has managed operational teams, developed processes across both clinical trial and post market activities, functioned as deputy EU QPPV / EU QPPV (prior to Brexit) and has been involved with merger and acquisition related activities such as safety database migration.  

As a consultant, Priya is particularly interested in developing and implementing compliant and pragmatic pharmacovigilance and quality systems and processes, through interpreting evolving regulatory obligations.

Priya is a guest lecturer at Kings College London (KCL), conducting lectures and workshops on GVP modules and case lifecycle management to Masters students studying Drug Safety, Ethics, Clinical Development or Medical Affairs.

Rym Hadj Kaddour has 12 years’ experience in the pharmaceutical industry, across both clinical safety and post-market pharmacovigilance sectors and within both Consultancy and Pharma roles.

In the past four years, Rym has focused on utilising her prior pharmacovigilance operational experiences in various areas to lead Global Pharmacovigilance and Drug Safety Operations during which time Rym has managed teams and developed processes across a range of PV activities. In addition, Rym has been involved in Pharmacovigilance Quality assurance activities which included leading and undertaking audit and inspection responsibilities.

Over her career, Rym functioned as deputy EU QPPV/ responsible person in the EU and on several occasion acted as a Local QPPV in the EU region and some ROW countries. Rym has also been involved with merger and acquisition related activities such as safety database migration.  

Rym key areas of focus include establishing PV systems, QMS development, PV and drug safety project management and leading operations.

Rym is a doctor in Pharmacy by profession, in addition to holding a University Diploma in Pharmacovigilance and drug safety from the University of Paris Descartes.

Susan Fitzpatrick brings more than 10 years of specialized experience in preclinical and clinical trial management, with a strong focus on patient safety. She has contributed to numerous academic and industry collaborations and has played a key role in guiding clinical trials from initial concept through Phases I–III and ultimately to successful regulatory approval.. 

Susan has deep experience in multiple facets of clinical patient safety, including; Protocol development, Generation of safety documents (e.g., IB, SAE narratives, safety management plans), Safety data monitoring, Clinical trial signal detection and evaluation, Risk analysis and mitigation, Management of adverse event and serious adverse event processes, Safety database review and reconciliation, Regulatory submission support (e.g., IND, CTA, CSR safety sections), Inspection and audit readiness, Safety training for investigators, site staff, clinical and operational teams, oversight of safety committees (e.g., Data Safety Monitoring Boards) 

Susan has successfully led clinical teams through trial start-up, maintenance, and close-out, and has served as a subject matter expert during audits and regulatory inspections. 

Susan holds a BSc (Honours) in Pharmacology and a PhD in Medical Science, both from University College Dublin.

Thomas has 9 years’ experience working across Health Professional and Pharmacovigilance roles. With foundation in based in community Pharmacy, Thomas offers experience working face to face with patients in a primary care setting. Developing a deep understanding of the patient relationship with medicines and the management of their health conditions.

Following introduction into Pharmacovigilance, Thomas has worked across both Consultancy and Pharma roles in a variety of Pharmacovigilance areas including case processing, signal detection, risk management and strategy planning, aRMM planning and implementation, aggregate safety reports, PSPs, MRPs, MAPs, PSMF, digital media, audits/inspections and vendor management.

Thomas has a strong focus for process development, creating efficiencies in complex workstreams and regulatory environments, and has worked extensively to drive system changes driven by Brexit related regulatory requirements. Thomas has led local implementation of several challenging risk minimisation measures including for products requiring a Pregnancy Prevention Programme.

Thomas strives to continuously improve the value of Pharmacovigilance systems by delivering practical and smart solutions that keep the patients’ needs in focus while ensuring regulatory compliance.