Patient Safety Partner

Primary Accountabilities :

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Implementation and maintenance of an effective local PV system for the country to ensure ongoing compliance with global Roche and local legal / regulatory authority PV requirements.

Support the oversight of the local PV system, including consistency in process execution, monitoring of the performance of the local PV system, proactive identification of actual or potential compliance gaps, and ensuring appropriate action is taken to prevent or resolve compliance issues.

Development and implementation of the local Patient Safety strategy, ensuring active contribution and partnership with local and global stakeholders.

Key Responsibilities :

Enabling a Transparent & Effective Local PV System

Support the holistic and comprehensive oversight of local PV compliance, including inspection readiness, and act as deputy point of contact for Safety, internally and externally, for safety-related aspects or as deputy Qualified Person for Pharmacovigilance (QPPV).

Contribute to the efficient, high-quality operational execution of Safety-related activities relevant to the PV system in partnership with the Pharmacovigilance Hub(s) to ensure monitoring of the safety profile of Roche products and their safety risk management, meeting regulatory requirements, and ensuring license to operate.

Support the implementation of Roche Safety Vigilance in the Affiliate and drive mindset and behaviors to advance PV customer centricity and value for patients.

Contribute to shaping and influencing the local safety regulatory environment, driving towards safer and robust healthcare systems.

Thought Partnership and Enablement to Advance Patient Safety Strategy

Connect with ecosystem partners and understand the wider Affiliate priorities, co-create solutions, and drive Safety partnership with affiliate and global functions to address customer safety needs.

Provide proactive safety expert support as a thought partner for patient-centric activities and projects, including product launches, precision medicine, and other strategic affiliate activities.

Act as a trusted point of contact for Global Safety and local colleagues for safety expertise for the assigned Disease Area or Therapeutic Area.

Implement the Patient Safety strategy in collaboration with other functions as part of the integrated disease area or therapeutic area strategy.

Proactively identify previously unmet safety needs and co-create and drive the local Safety strategy aligning with the global safety strategy.

Collaborate to generate actionable safety insights that matter to patients, HCPs, and the business.

Horizon scanning for trends and opportunities to enable acceleration and scalability of Patient Safety initiatives and patient solutions.

Catalyze Self-Management of the Affiliate Patient Safety Team

Ensure business continuity and collaborate with line management and cross-country network on resource activities to ensure appropriate prioritization and resource allocation.

Pull in expertise and resources locally and from the Safety network as needed, and contribute expertise as part of the Safety NET to co-create solutions.

Drive continuous improvement of local safety capabilities in operational PV and safety science expertise.

Qualifications

Passionate about Patient Safety and understanding of Pharmacovigilance.

MD / HCP qualification is a prerequisite.

Experience

Experience in PV, particularly in an affiliate setting (ideally, at least 1-3 years).

Experience in other affiliate medical functions or global clinical product development is considered advantageous.

Technical Skills and Competencies

Good knowledge and understanding of new molecules / new therapeutic areas, digital health, data, and insights.

Experience and expertise in Pharmacovigilance and local & Global PV ecosystem decision-making.

Ability to design, implement, and maintain PV processes and oversight systems that are effective and efficient.

Good understanding of other functions, drug development, market access, and PV, with the ability to work cross-functionally.

Deep understanding of the local environment and proven abilities to develop important partnerships internally and externally.

Strategic mindset, systems thinker, critical thinking skills, and outcome-based planning.

Customer-centric mindset with a strong understanding of patient journeys and related Roche products / integrated healthcare solutions.

Ability to inspire the Safety vision and move the ecosystem from PV reporting to Patient Safety.

Support the team to think critically and increase safety awareness.

Digital mindset to communicate and utilize resources and expertise from the network.

Ability to contribute to the network with co-creation of solutions and share experiences.

Agility to thrive in a dynamic environment undergoing transformational change.

Externally focused : proactively monitor the external landscape to understand trends, competitive activity, risks, and opportunities.

About Us

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