Patient Safety Specialist

**Major accountabilities**:

- **Manage 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. Advocate for the needs of the affiliate at regional and global level to ensure that safety requirements are well supported
- **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 to other functions in the affiliate, to ensure their safe and effective use, specifically through implementation of risk management plans and risk minimization measures.
- **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), to ensure that they are well executed and satisfy quality and compliance expectations.
- **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.

**Major Accountabilities**

**Local Pharmacovigilance Qualified Person/National Pharmacovigilance point of the contact**:Serve as the Single Point of Contact or Deputy for Pharmacovigilance, ensuring 24-hour availability where required by local PV laws. Act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance, as defined by local regulations, and maintain direct communication with the Local Health Authority on Pharmacovigilance matters.

**Communication flow**:In collaboration with a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region, ensure effective communication channels with local Affiliate(s), Patient Safety Regional lead(s), the EU-QPPV and third-party vendor(s). Ensure a two-way exchange of key information related to the Pharmacovigilance system within the local Affiliate(s), enabling PV system oversight and proactive risk mitigation in case of any occurred or potential non-compliance or safety issues.

**Management of Safety Information**

**Case processing**:
**Supervise Local Case Management**:Ensure effective supervision of all case management activities within the local Affiliate(s), maintaining high standards of accuracy and compliance (note: case management may be partially or fully outsourced to third-party vendors).

**Coordinate with Third-Party Vendor(s) and process owners**:Collaborate with third-party vendor(s) and process owner(s) to ensure seamless integration and execution of outsourced case management activities.

**Ensure Regulatory Compliance Oversight**:Guarantee that all case management activities comply with local regulatory requirements, including case submissions. In the event of detected non-compliances, collaborate with PS regional lead(s), process owner(s), Quality Assurance, and third-party vendors to implement timely corrections.

**Product Quality Complaints**:Maintain awareness of product complaints received within the local Affiliate(s). Ensure the exchange and reconciliation of product complaints associated with adverse events and escalate any suspicions of product quality issues that may be the root cause of adverse events according to established process.

**Periodic reports**:Collaborate with local, regional, and global teams to plan and ensure timely submission of periodic reports in compliance with local regulations. Coordinate with global functions, process owner(s) and third-party vendors to prepare and submit these reports.

**Local Literature**:Collaborate with local medical functions to periodically (at least once a year) identify relevant local journals for literature searches. Ensure that these journals are periodically screened by a third-party vendor in accordance with legislative requirements.

**Support Business Activities**:Collaborate in the setup of local programs and other local activities that may elicit adverse events and safety-relevant information. This includes implementing reporting pathways, data reconciliation, and source data verification for various progra