Manager Patient Safety

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz

**The Manager Patient Safety (Belgium & Luxembourg) is responsible to**:
**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 Key Responsibilities**:
Your responsibilities include, but not limited to:

- **Leadership**:
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 Europe and 3rd party vendors.
- **Communication flow**:
In collaboration with the Sandoz regional Hubs and the 3rd party vendor operational hubs, ensure that communication flows for safety processes including any **local sources of safety data **and **safety issues **are identified and implemented.
- **Single point of contact**:
As defined by local regulations act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance in the country(ies) and act as the single point of contact with the Local Health Authority. Be contactable on a 24 hours a day, 7 days a week.
- **Management of Safety Information**:

- Management of Adverse Events**:Ensure the local management of adverse event information, Identification of sources of adverse event information, Maintaining oversight on case content and reporting.
**- Management of Periodic reports**:planning and oversight.
**- Management of Local Literature in **collaboration with 3rd party vendor.
**- Support business in the set-up of programs **and any other activities that may elicit adverse event and other safety relevant.
- **Sandoz product safety profiles and related actions**:

- 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.
- **Awareness of Sandoz product safety profiles **.
- **Risk Management**: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks. - Ensure readiness to implement ad hoc safety measures.
- **QMS and supporting processes**:

- Local Procedures**:Ensure the local Pharmacovigilance requirements are met. Where required, implement local procedures to supplement PS global procedures.
**- Trainings of **local internal and external stakeholders on pharmacovigilance obligations.

Monitor internal compliance for local processing and external compliance.
**- Audits and Inspections**:In cooperation with the 3rd party vendor, partner functions and management maintain audit/inspection readiness and manage local Pharmacovigilance audit/inspection.
**- Deviation and CAPA management**
**- PV Agreements**
**- Regulatory Intelligence **.
**- Local 24hr accessibilit