Manager QPPV Office (Hyderabad)

Manager QPPV Office (Hyderabad)

18 Sep
|
Sandoz
|
Hyderabad

18 Sep

Sandoz

Hyderabad

Job Description Summary
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 current and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape

To support the EU-QPPV and Head QPPV Office with activities required to ensure compliance with Guidelines on Good Pharmacovigilance Practices (GVP) and other applicable worldwide PV regulations and to fulfil role requirements as indicated below.

Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Ensure the end-to-end maintenance, development and submission of the UK PSMF/sPSMF and support that of the EU PSMF.
- Support the development, management and implementation of deviations and associated CAPAs across the Patient Safety organization
- Support inspection and audit operations, including CAPA development, tracking and management
- Support the development,



implementation and dissemination of PS procedures
- Support QPPV in meeting legislative requirements as per relevant legislation
- Any other activities to support the QPPV office as assigned

Person specific / special tasks:
- Ensure the end-to-end maintenance of the UK PSMF working with the appropriate local and global stakeholders for the Core and Annex documents. This includes lead authoring and update of the UK PSMF, and Pharmacovigilance System Summary (sPSMF) for the pharmacovigilance system of Sandoz. This includes the management of cross-functional contributors of the Sandoz PSMF and independent identification of changes to the global PV system which require an update particularly to the UK PSMF in close collaboration with Operations Manager, QPPV Office.
- Work closely with Operations Manager, QPPV Office to ensure accurate representation of the Sandoz PV system in line with regulatory requirements and incorpora

📌 Manager QPPV Office (Hyderabad)
🏢 Sandoz
📍 Hyderabad

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