Country Patient Safety Manager Cz/svk Prague, Praha

Country Patient Safety Manager Cz/svk

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Join us as Patient Safety Manager of our ‘new’ Sandoz!
**Lead pharmacovigilance activities in the Sandoz affiliate, **in the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system, to ensure that local safety procedures are comprehensive, effective, compliant and well embedded in the cross-functional and global-regional-local environment.
**Influence the affiliate organization **as a key member of the affiliate organization with high visibility, to promote a thorough understanding of the pharmacovigilance system, adherence to safety requirements for local activities.
**Ensure the seamless flow of safety relevant information, **within the affiliate, with local business partners and with regional hubs and 3rd party vendor in accordance with the Sandoz patient safety operating model.
**Maintain awareness on safety profiles of Sandoz products **and provide safety expertise and support for all marketed and investigational products - drugs and combination products - to other functions in the affiliate.
**Establish or participate in oversight mechanisms on safety activities, **specifically those outsourced to vendors on behalf of the affiliate (local activities, such as in patient-oriented programs as well as core safety activities, and core safety activities, such as case handling and periodic report generation).
**Participate in the maintenance of the local quality management system, **including training, records management, regulatory intelligence, audit and inspection readiness, in collaboration with local, regional and global functions, business partners and vendors.
**Your responsibilities include, but not limited to**:
- Build strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director Patient Safety HUB/ Associated Director Patient Safety HUB and 3rd party vendors
- Management of Adverse Events: Ensure the local management of adverse event information, with the following aspects (In collaboration with 3rd party vendor routine operational activities may be partially or completely outsourced)
- Product Complaints management: Maintain awareness of product complaints received in the affiliate, ensure exchange and reconciliation of product complaints associated with adverse events
- Management of Local Literature: In collaboration with 3rd party vendor, identify the local journals required for screening, maintain overview on search results specifically any potential safety signals or aspects relating to benefit/risk
- Health Authority Requests (and other externally generated signals): In collaboration with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities
- Risk Management: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks. Ensure the country oversight of implementation of Post Authorization Safety Studies and additional Risk Minimization Measures at local level
- QMS and supporting processes: Ensure the local Pharmacovigilance requirements are met. Identify specific requirements that may not be covered by global procedures and communicate to the Sandoz regional hub. Where required, implement local procedures to supplement PS global procedures and to ensure compliance national requirements
- Audits and Inspections: In cooperation with the 3rd party vendor, QA and other applicable groups, maintain audit/inspection readiness with the support of regional hubs and 3rd party vendor and manage any local Pharmacovigilance audit/inspection. Contribute as Pharmacovigilance SME, in other internal Sandoz audits and/or third-party audits, as applicable
- Sandoz Patient Safety Governance: Collect and share relevant metrics for local business volumes and performance. Participate in governance meetings at regional and global level to have oversight on the performance of the PV system
- Affiliate Governance: participate or maintain awareness of key governance meetings in the affiliate to stay informed of important developments in the affiliate that may have an impact on the conduct of safety activities
- External governance: Build relevant external interfaces with local distributors, license partners, vendors to collaborate on day-to-day matters and oversee the adherence to safety relevant obligations of contracts and PV agreements
- External relationships: build relationships with health authorities, industry as-sociations, healthcare professionals, patients and caretakers etc..
- Novartis is committed to building an outstanding, inclusive work e

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