Meet our Team

Head of PV

Kate Chasmar

Kate Chasmar has over 18 years of experience in end-to-end clinical safety and pharmacovigilance. Her expertise was gained from working across small-to-medium CROs, specialist PV Providers and big Pharma. She has worked on all development and marketing stages, from small phase I studies through to large post-marketing portfolios. Her knowledge ranges across multiple product types (e.g., drugs, devices, combination, ATIMPs). Kate has led multiple teams responsible for clinical safety and post-marketing pharmacovigilance services for customers ranging from small biotech to large generic companies.

Associate Director of PV

Shreya Menon

Shreya graduated from Rajiv Gandhi University of Health Sciences as a qualified Dentist. She has over 11 years of experience in the PV and CRO industry. Her expertise in clinical trials and post authorization activities including set up and maintenance of PV systems across a diverse range of therapeutic areas.

Shreya also has an in-depth knowledge of safety database and administrator for adverse event system. She is an ambitious healthcare professional passionate about collaborating with and supporting clients in the development of their products.

Medical Advisor

Joy Chukwujindu

Joy has more than 20 years experience in Drug Safety Physician roles. Joy is medically qualified. She is a UK GMC Registered Physician with Licence to Practice. She has UK Specialist Accreditation in Pharmaceutical Medicine and is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians. Her skills encompass all aspects of global drug safety from Phase I to Post-marketing including Signal management process and procedures; Safety databases - ARISg, ARGUS, BaseCon, In-house databases; Supporting filing for new indications; Writing and reviewing CTD and RMPs; Responding to Regulatory Authority queries during filing activities; Attending meetings with Regulatory Authorities; EU Pharmacovigilance regulations; EU QPPV; MedDRA coding; Defining MedDRA Baskets for cumulative reviews; PSURs, PBRERs, DSURs, ICSRs medical reviews; Safety in clinical trials; Post-marketing safety; PASS; Compiling/reviewing safety sections CDS/SPC/IB in line with Regulatory Guidance.

PV Project Manager

Imogen Burkinshaw

Imogen has over 16 years of experience in pharmacovigilance, from a number of mid to large size pharmaceutical and service provider companies. She has experience in both clinical trials and post authorisation, as well as extensive experience in a variety of therapeutic areas such as oncology, endocrinology, cardiovascular, gastrointestinal, and OTC products.

Her expertise is in set up and maintenance of multiple full scope PV projects, including EudraVigilance maintenance and regulatory submissions. Imogen is responsible for the overall delivery, quality, and compliance across all projects, and also chairs the QVigilance PV Quality Governance Committee.

 

Drug Safety Consultant

Dragutin Rafailović

Dr. Rafailović is an experienced Drug Safety Physician with a demonstrated delivery of medical, clinical, and scientific advisory expertise in clinical research studies and post marketing programs, signal detection and aggregated reporting. His skills include medical review, medical writing, signal detection, medical monitoring, literature review, clinical research, and client/staff training.

He has 10 years of experience in providing advanced pharmacovigilance services to multiple customers with medicinal products in various phases of their lifecycle, including clinical development and marketed products. He also served as physician for 2 and a half years at the Clinic of Urology, Clinical Center of Serbia.

Quality Assurance Manager

Randip Sanghera

Our QA Manager, Randip Sanghera has over 20 years experience in the CRO and Pharmaceutical Industry. She started out as a CRA and then moved to QA.  

Her responsibilities include: ensuring quality via the internal and external audit program; consulting with all staff on the regulatory requirements and quality issues; assisting in the maintenance of the Quality Management System of QVigilance; managing and hosting clients audits and regulatory inspections (GCP/GMP and FDA inspections); identifying quality improvements in GxP activities.

 

IT Service Manager

Vimal Xavier

Vimal Xavier joined QVigilance in 2017 to accept overall responsibility for global IT service desk and support. Vimal has over 15 years’ experience of IT Support and management within CRO and IT sectors and is also certified in ITIL and Microsoft solutions (MCP).

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