Senior Specialist, Country Patient Safety

As a Patient Safety Executive, you will take main responsibility for leading pharmacovigilance activities in the Sandoz affiliate, influencing the affiliate organization, ensure the seamless flow of safety relevant information, maintain awareness on safety profiles of Sandoz products, establish or participate in oversight mechanisms on safety activities and participate in the maintenance of the local quality management system.

**Main Accountability**:

- 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), give assistant the Director Patient Safety HUB/ Associated Director Patient Safety HUB 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 [and 24hr availability]: 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 [on a 24-hour basis where required].
- Management of Safety Information: Lead all aspects of adverse event management, product complaints, periodic reports, local literature, and support business in setting up programs.
- Sandoz product safety profiles and related actions: Handle Health Authority Requests, maintain oversight on signal management process, and implement risk management measures.
- QMS and supporting processes: Ensure compliance with local Pharmacovigilance requirements, train stakeholders, manage records, and participate in audits and inspections.
- Governance: Collect and share relevant metrics, participate in governance meetings, build external relationships, and escalate issues when necessary.
- Projects: Participate in initiatives, lead business improvement activities, and contribute to mentoring and continuous education of PS staff.

SANDOZ
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
- Fluent in written and spoken local language and English
- Minimum 2 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
- Demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry.
- Knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
- Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. Ability to effectively communicate with different stakeholders.
- Experience in PV audits and inspections.
- Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
- Experienced in a matrix organization, including ability to influence and provide guidance and direction to team members.
- Proven ability for innovative and big picture thinking.
- Strong planning, negotiation, organizational and interpersonal skills.
- Computer/IT systems literacy.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 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, innovative 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.

The future is ours to shape