Psmf Coordinator, Qppv Office

1 week ago


Telangana, India Sandoz Full time

**Major accountabilities**:

- Plan and maintain timetables for PSMF production. Maintain list of core and annex contributors, and PSMF signatories plus their deputies. Coordinate production of core PSMF documents in collaboration with internal and external contributors.
- Work closely with Manager, QPPV Office to ensure accurate representation of the Sandoz PV system in line with regulatory requirements and incorporate identified changes into the PSMF in a timely manner.
- Track timely provision of information from stakeholders for PSMF production, escalating issues to the Manager, QPPV Office. Format and publish final PSMF, ensuring consistency.
- Coordinate review, approval and signatures for PSMF. Create Summary Pharmacovigilance System Master File (sPSMF) documents where required. Maintain PSMF trackers, and the PSMF document in archive and at agreed web sites.
- Support Manager, QPPV Office in provision of documents required by CPSRs to create local PSMFs / Pharmacovigilance Subsystem Files (PSSFs) as required. Support Manager, QPPV Office in tracking of submission of PSMF documents as required.
- Support QPPV office in audit and inspection organization and logistics activities as required. Support QPPV office with other tasks as required.
- Review process based on experience, feedback and requirements, lead continuous process improvement.

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Join us

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Sandoz

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