Deputy EU QPPV

Deputy EU QPPV Sandoz Holzkirchen, Germany Your Key Responsibilities: Your responsibilities include, but not limited to: Act as the formally designated Deputy EU QPPV during agreed periods of absence and perform delegated QPPV activities in accordance with applicable legislation, GVP requirements, and internal procedures. Support continuous availability of an appropriately trained QPPV or deputy contact for EU/EEA competent authorities and coordinate timely responses to pharmacovigilance-related requests. Support the EU QPPV in maintaining oversight of the structure, performance, and quality of the global pharmacovigilance system, including outsourced and delegated activities. Maintain appropriate awareness of product safety profiles, emerging safety concerns, and conditions or obligations associated with marketing authorisations and risk-minimisation measures. Support oversight of key pharmacovigilance activities, including case management, signal management, aggregate reporting, risk management, safety variations, partner interfaces, and regulatory commitments. Participate in safety governance forums and provide QPPV input to significant safety decisions, benefit-risk evaluations, and proposed regulatory actions. Support maintenance of the Pharmacovigilance System Master File and ensure that QPPV oversight, decisions, delegation, and supporting evidence are appropriately documented. Monitor relevant compliance metrics, KPIs and KQIs, deviations, CAPAs, audit and inspection findings, and ensure significant risks are escalated promptly to the EU QPPV and appropriate governance bodies. Contribute to pharmacovigilance inspection readiness and participate in regulatory inspections and internal or external audits, including oversight of timely and effective remediation. Provide expert pharmacovigilance advice and collaborate with Patient Safety, Medical, Regulatory Affairs, Quality Assurance, Clinical Development, Commercial, Legal, and other relevant functions. Support development and maintenance of QPPV Office procedures, business continuity and coverage arrangements, governance processes, and relevant training. Coach and mentor colleagues supporting QPPV activities and promote a strong culture of patient safety, quality, transparency, and regulatory compliance. What you ll bring to the role: Essential Requirements: Minimum: Degree in medicine, pharmacy, life sciences, or another relevant healthcare or scientific discipline. Substantial experience in pharmacovigilance or drug safety, including senior responsibility for PV compliance, safety governance, or system oversight. Strong knowledge of EU pharmacovigilance legislation, Good Pharmacovigilance Practices, and relevant international safety requirements. Broad understanding of benefit-risk evaluation, signal management, risk management, aggregate reporting, case processing, quality systems, audits, and inspections. Prior QPPV, Deputy QPPV, local QPPV, or equivalent senior pharmacovigilance experience is desirable. Demonstrated ability to influence cross-functional stakeholders and make risk-based decisions in a complex regulated environment. Strong scientific judgment, integrity, accountability, communication, collaboration, and effective escalation skills. Ability to operate calmly and effectively under time-critical conditions with strong attention to detail. English: fluent written and spoken. Additional languages are an advantage. Apply Now