My client is leading international Pharmaceutical company with a UK hub based in Slough.
Following recent European wide commitment to expanding its PV capability, they are now looking to hire an experienced Senior Pharmacovigilance Scientist who will support and deputise for the Associate Director GPV in the effective delivery of Pharmacovigilance & Device Vigilance activities for all products (both commercialised and under development).
Your primary responsibility will be to provide a significant contribution for maintaining the operational drug and device safety processes and systems, whilst being accountable for leading specific processes contributing to compliance of the overall Pharmacovigilance system
Oversee the vendor quality for PSURs, Signal Detection, RMPs, ICSRs and management of the safely database
Responsible for enduring pharmacovigilance service provider delivery including timeliness and quality of PSURs, Signal Detection and RMPs
Responsible for KPIs and summary statements for pharmacovigilancedashboard for benefit risk activities and pharmacovigilanceoperations
Support in the creation and maintenance of the Pharmacovigilance master file
Participate in the business activities such as studies, patient support programs, market research, social media, website, digital application to ensure compliance with pharmacovigilance requirements
Responsible for the creation and maintenance of pharmacovigilance processes and procedures, documented in company Standard Operating Procedures, Guidelines and User Manuals. Contribute to their effective implementation through targeted training activities
Managing and being responsible for the benefit risk review process in the context of signal detection and RMP preparation and maintenance
Coordinate the production of aggregate periodic reports (i.e. PSUR, DSUR) by the designated service provider, including Quality Control (QC)