Deval Kotadia

Uk-qppv Uk -ncp and Vigilance Specialist @ProductLife Group

Cambridge, GB

As a UK Qualified Person for Pharmacovigilance (QPPV) for selected MAH/clients• Have access and authority to the pharmacovigilance system master file (PSMF) to ensure and to verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system • QPPV has an oversight over the functioning of the system in all relevant aspects, including its quality system • having an overview of medicinal product safety profiles and any emerging safety issues • Maintaining a continuous oversight on the changes in the risk-benefit profile and signal management of the product. • Acting as a single pharmacovigilance contact point for the MHRA on a 24-hour basis and as a contact point for pharmacovigilance inspections. • Oversight of the ICSRs safety database/system and validation status.• Having awareness of risk minimisation measures and having sufficient authority over the content of risk management plans.• Ensuring submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP.• Ensuring that any request for information from the UK authorities in relation to any medicinal product for the benefit risk assessment is answered fully and within specific time frame.• Providing input into the preparation of regulatory action in response to variations, and safety communication)• Having awareness of post authorisation safety studies and protocol (as applicable).• Overview and ensure timely and accurate submission of ICSRS, PSURs, RMPs and other safety and regulatory documents.• Participate in safety meetings, annual meetings, recall meetings with the MAH/clients and involve in decision making process.• Participate in audit and inspections• Support in CAPA review, implementation, and review of deviations.• Backup in the absence of the QPPV.Act as UK National Contact person (NCP) reporting to UK QPPV, for selected MAH/clients.

JSS Academy of Higher Education & Research

M PHARM, Pharmacology

Liverpool John Moores University

Master of Public Health - MPH, Public Health

Soniya Education Trust's College of Pharmacy

B Pharm, Pharmacy

Sheth C M High School.

H.S.C. G.S.E.B; S.S.C. G.S.E.B, 2002 Science; 2000 General