Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
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
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Deputy EU QPPV (m/f/d) Arbeitgeber: Sandoz
Sandoz bietet eine hervorragende Ausbildung für angehende Metalltechniker in einem dynamischen und unterstützenden Umfeld. Unsere Mitarbeiter profitieren von einer offenen Unternehmenskultur, die Teamarbeit und persönliche Entwicklung fördert, sowie von attraktiven Vergütungen und flexiblen Arbeitszeiten. In dieser Rolle hast du die Möglichkeit, wertvolle Fähigkeiten zu erlernen und deine Karriere in der Metalltechnik zu starten, während du Teil eines innovativen Unternehmens bist.
