Nisha is a Senior Pharmacovigilance (PVG) Project Manager and a key member of the Bionical Emas PVG team since 2011, seeing the department grow from supporting a handful of clients to over 50 clients, ranging from start-up biotech and Phase I units to large Pharma companies.
As a Senior PVG Project Manager, Nisha supports clients by delivering a seamless, personalised PVG offering, be it for investigational products in the clinical trial setting, in early access program (EAP) use, or for establishing a pharmacovigilance system for a licensed product portfolio.
Working across products at different stages in the lifecycle, there are no two days that are the same! For clinical study clients, Nisha ensures set up of a system for the collection of serious adverse events (SAEs), to allow for timely case processing and compliant submissions to global regulatory agencies, ethics committees and investigators. Further support is provided to clients in the form of Development Safety Update Report (DSUR) preparation, Investigator’s Brochure (IB)/protocol reviews, management of Data and Safety Monitoring Board (DSMBs) and preparation of PVG documentation for eTMF readiness. In the post marketing setting, Nisha supports clients by establishing a global pharmacovigilance system, including provision of the European Economic Area Qualified Person Responsible For Pharmacovigilance (EEA QPPV) and local QPPVs, case management, global literature review, signal management, PVG system master file (PSMF) preparation and maintenance, aggregate report preparation, EudraVigilance /XEVMPD registration/maintenance, Risk Management Plan (RMP) review and Safety Data Exchange Agreement (SDEA) development.
In the EAP setting, whilst the primary goal is to provide urgent treatment, generally, safety data collection and regulatory authority submission is a requirement. This provides an opportunity to obtain quality data from a more diverse population, which can be supplementary in informing regulatory agencies, Health Technology Assessment (HTA) bodies, payers, clinicians and patients. Operationalising an EAP requires coordination of multiple stakeholders. Bionical Emas are uniquely positioned with a PVG team working across the Clinical Development and EAP divisions, with PVG supporting over 20 early access programs delivering life-changing medicines to patients in desperate need. Nisha works in close collaboration with the EAP division to ensure PVG requirements per local regulations are addressed, utilising either Bionical Emas systems including a safety database and PVG processes or working to clients existing processes and systems.
Looking ahead, the PVG team are excited to implement Veeva Vault Safety, coming in April 2021, providing our clients with a drug safety solution for the collection, management, and real-time oversight of adverse events arising from clinical trials, early access and post-marketing use, enabling more informed decisions and maintenance of excellent compliance with an ever-increasing safety report load.