Senior Drug Safety Associate

Our client, a global pharmaceutical company, are looking for a Senior Drug Safety Associate to join their team in Maidenhead for a 6 month+ contract (inside IR35)

Senior Drug Safety Associate Responsibilities:

• Responsible for all local Pharmacovigilance-related activities for the UK and Ireland affiliate.
• Collection and timely reporting of all adverse events/safety reports to GSRS or external provider as defined both by internal SOPs and UK and Irish regulations
• Assisting in Audit & Inspection readiness as required and assisting with audits/monitoring visits of external third-party vendors
• Responsible for the overall provision of safety report handling relating to BI UKIMaintenance of local PV processes and procedures
• Training and tracking of all external providers on appropriate PV-related procedures
• Ensuring awareness of any programmes/contractual arrangements with external providers with significance for handling AE information according to relevant procedures
• Review of external provider reports for AEs and PCs
• Tracking of safety reports from a variety of sources within specified timelines
• Reviewing and tracking local literature for safety-related content
• Maintaining oversight of outsourced vendors with PV responsibilities
• Assisting GSRS with regulatory requests or audits/inspections
• Assisting with monthly reports on PV metrics
• Assisting with PV Operations Vendor’s compliance and follow-up activities
• Tracking safety data exchange agreements
• Responsible for PV oversight for Company’s patient support programs and homecare
• Assisting GSRS with late case investigations
• Overseeing PV-related CAPA/Exception management GSRS/IPV 100%
• And other job duties that may be assigned. May be modified at any time as business needs require.

Senior Drug Safety Requirements:

• Primary life sciences degree/qualification
• Minimum of 3 years of industry PV industry experience
• Knowledge of local regulations
• High attention to detail
• Ability to work independently on routine and new assignments
• Good experience of working in an affiliate environment
• Experience of working with homecare companies and patient support programs
• Process driven with ability to set work systems, procedures and track performance
• Understanding of commercial business needs and strategy
• Significant experience of ICSR processing and quality checking

If you are interested in discussing further, please contact Rosie Bayliss at Planet Forward on 02038900116 / rbayliss@theplanetforward.co.uk

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