About Me

An Independent Life Science Consultant based in the United Kingdom. With over 15 years of experience, I specialise in post-Marketing Pharmacovigilance, Medical Information, and strategic advisory roles.

What I do

Implement Effective Systems

I've successfully implemented Pharmacovigilance & Medical Information Systems to ensure they run smoothly and efficiently.

Develop Training Modules

Created comprehensive PV & GVP Training Modules to enhance knowledge and skills in the field.

Streamline Processes

Merged multiple Pharmacovigilance systems and established streamlined PV systems, including the QPPV office and LSOs.

Harmonize Agreements

Worked on business process harmonization of Pharmacovigilance Agreements to ensure alignment and efficiency.

My Expertise

System Integration: Development and integration of Pharmacovigilance & Medical Information Systems.
Audit Preparation: Ensuring Audit & Inspection Readiness Preparation.
Process Optimisation: Enhancing process efficiencies and optimization across critical PV areas.
Cross-Functional Alignment: Integrating processes with Quality Management for better alignment.
Project Management: Operational supervision and project management across multiple PV areas.
Strategic Assessment: Conducting gap analysis, impact assessment, and strategic vendor assessment.

Director & GVP/Veterinary PV Auditor, Collaborative Pharma Ltd

As the Director of Collaborative Pharma Ltd, Janine has established herself as a leading consultant and auditor in pharmacovigilance.

Her key responsibilities include creating and maintaining the UK Pharmacovigilance System Master File (PSMF), conducting comprehensive gap analyses, and optimizing internal systems to enhance operational efficiency and compliance. Janine’s expertise extends to providing UK QPPV/UK NCP support and delivering tailored solutions for clients in the pharmaceutical and veterinary sectors.

Manager Consumer Services & UK NCPV

In this role, Janine successfully restructured the UK pharmacovigilance system, ensuring alignment with regulatory requirements. She performed quarterly audits, managed the Consumer Services team, and oversaw local case handling and reporting activities.

Her ability to collaborate effectively with regulatory, marketing, and legal teams ensured seamless operations and a robust local PV system.

Contract Pharmacovigilance Partnering Specialist

Janine provided strategic oversight for safety data management and safety agreements. She advised stakeholders on contractual arrangements, facilitated the transfer of safety data during acquisitions, and ensured the documentation of roles and responsibilities in line with global standards.

Medical Affairs Specialist

Janine played a pivotal role in managing the UK pharmacovigilance and medical information systems, driving continuous improvement initiatives, and ensuring compliance with regulatory authorities. She oversaw regulatory affairs, conducted internal and external audits, and led cross-functional projects in quality, pharmacovigilance, and scientific affairs.

Deputy QPPV/RPP and Senior PV Roles

In her earlier roles, Janine demonstrated her proficiency in drafting safety management plans, chairing safety review meetings, and maintaining critical pharmacovigilance documentation, including PSMFs and risk management plans. Her contributions were instrumental in ensuring the safety and compliance of marketed products.

Early Career in Clinical Research and Data Management

Janine’s career began in clinical research and mental health, where she gained valuable experience in managing trial documentation, volunteer recruitment, and data processing. These foundational roles provided her with a strong understanding of quality control, regulatory compliance, and operational efficiency.

Education and Professional Development

Janine holds a BA in Criminology and Sociology from Anglia Ruskin University, complemented by certifications in psychotherapy, anatomy, and nutrition. Her dedication to continuous professional development is evident through her completion of CPD-accredited courses in pharmacovigilance auditing, risk assessment, and quality management.

Professional Affiliations

Janine is a distinguished Honorary Fellow of the Pharmaceutical Information and Pharmacovigilance Association (PIPA) and a member of the Research Quality Association (RQA). As a former Vice-President of PIPA, she has been instrumental in upholding and advancing professional standards within the industry.

My Journey

Throughout my career, I’ve held various roles that have shaped my expertise