PATIENT SAFETY LEAD

At Roche, we believe it is critical to deliver medical solutions now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientic rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Purpose

The Patient Safety Lead plays a pivotal role in developing and implementing the local Patient Safety strategy, ensuring alignment with Roche Pharma’s vision and full compliance with both global and local PV requirements. Through creative leadership and active partnership with internal and external stakeholders, this role enables a strong safety culture, supports the Patient Safety Partner team, and ensures sustainable impact on patients and healthcare systems. Acting as a Visionary, Architect, Catalyst, and Coach, the Patient Safety Lead drives excellence, innovation, and talent development within the safety network.

Responsibilities:

As a Patient Safety Lead, you will:

• Implementation and maintenance of an effective local pharmacovigilance (PV) system for Serbia and Montenegro to ensure ongoing compliance with global Roche standards and local regulatory requirements; will also serve as the Qualied Person Responsible for Pharmacovigilance (QPPV) for Serbia, acting as the primary contact for the national competent authority and ensuring full adherence to local PV obligations.
• Oversight of all aspects of the local PV system. This includes consistency in process execution, monitoring of the performance of the local PV system, proactive identication of actual or potential compliance gaps, and ensuring appropriate action is taken (including escalation to local and global senior management, as applicable) to prevent or resolve compliance issues.
• Development and implementation of the local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders and impact by the team of Patient Safety Partners to the Pharma Vision.
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Requirements & Qualications:

Education/Qualications

✔ Passionate about Patient Safety, and understanding of Pharmacovigilance - may be a e.g. MD, HCP, PHD in life sciences, Master in Public Health / Pharmaceutical Medicine, etc.

Experience, Skills, Knowledge

✔ Signicant experience relevant to PV in an afliate setting (at least 3-5 years).
✔ Experience in other afliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development, clinical safety is considered advantageous.

Technical Skills and Competencies

✔ Experience and expertise in Pharmacovigilance and how decisions are made in the local & Global PV ecosystem.
✔ Ability to design, implement, and maintain PV processes and PV oversight systems that are straightforward, effective, and efcient.
✔ Good understanding of other functions & pharma business, drug development, market access and PV, and ability to work cross-functionally as well as navigate through complexity.
✔ Deep understanding of the local environment and proven abilities to develop important partnerships internally and externally, including inuencing of, and negotiating with key personnel in an afliate.
✔ Strategic mindset, systems thinker, critical thinking skills and outcome-based planning.
✔ Customer centric mindset with a strong understanding of patient journey(s), health systems and related Roche products/integrated healthcare solutions
✔ VACC leadership growth-mindset (moving from the operational aspects to the development of safety strategy)

Visionary: inspire the Safety vision (int + ext).
Cathalizer: moving the ecosystem from PV reporting to Patient Safety.
Coach: support the team to think critically and increase safety awareness

✔ Digital mindset as second nature to communicate, and to utilize resources and expertise from the network to fulll local needs.
✔ Ability to contribute to the network with co-creation of solutions and share experiences. Able to simplify knowledge and adapt it to local needs.
✔ Agility: ability to ex and thrive in a dynamic environment undergoing transformational change.
✔ Externally focused: proactively monitors the external landscape to understand and communicate trends, competitive activity, risks and opportunities.

Should you answer the above challenges and requirements with YES then this is the right position for you!

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

We believe in the power of diversity and inclusion and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.