Roles & Responsibilities:
• Ensure MAH pharmacovigilance compliance with EU GVP Modules and UK MHRA requirements
• Act as operational PV representative for UK and EU markets
• Support QPPV / UK QPPV in maintaining PV system oversight
• Ensure PV agreements with partners, distributors, and service providers are in place
• Provide oversight of outsourced PV providers (ICSRs, literature, signals, aggregate reports)
• Monitor vendor performance against KPIs and SLAs and lead governance meetings
• Ensure timely and compliant ICSR reporting to EudraVigilance, MHRA, and partners
• Oversee PSUR/PBRERs, RMPs, signal management, and benefit–risk evaluations
• Maintain MAH PV Quality Management System and ensure SOP compliance
• Support PV inspections and audits (MHRA, EMA, partners) and manage CAPAs
• Act as PV contact for Regulatory, Quality, and Commercial teams
• Ensure safety information is accurately reflected in SmPC, PIL, and submissions
Qualifications:
• M.Pharma in Pharmacy
Experience:
• Proven pharmacovigilance experience within UK and/or EU
• Experience working in an MAH environment
• Hands-on experience managing outsourced/third-party PV providers
Skills:
• Strong regulatory and compliance mindset
• Excellent vendor and stakeholder management skills
• Strong documentation, review, and inspection readiness abilities
• Ability to work independently and manage multiple priorities
• Experience in generics and post-marketing PV
• Exposure to global PV operations and EudraVigilance systems
About the Organization:
B&S Group is a global distribution and supply chain organization operating across pharmaceuticals and healthcare, with a strong focus on regulatory compliance, quality, and patient safety across international markets.
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