Patient Safety Lead

5 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia F. Hoffmann-La Roche Gruppe Full time

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Primary Accountabilities

  • Implement and maintain an effective local PV system for the respective affiliate(s)/country(ies) to ensure ongoing compliance with global Roche and local legal / regulatory authority PV requirements.

  • Have an 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 identification 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.

  • Develop and implement 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.

  • Actively 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, meet regulatory requirements, and ensure license to operate.

Note: Depending on country set-up and end-to-end process support by the PV Hub, the Patient Safety Lead may be primarily responsible, or involved in parts of operational execution of the above procedural areas, in accordance with Roche standard operating procedures.

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

  • As an active member of the local ecosystem, lead in shaping and influencing the local safety regulatory environment driving towards safer and robust healthcare systems, working with partners such as local pharma industry associations, healthcare organizations, patient and patient groups etc.

  • Ensure business continuity and collaborates with line management, cross-country network on resource activities to ensure appropriate prioritization and resource allocation to deliver key focus areas and outcomes, and provide feedback to ensure the right skills and expertise are deployed to the team.

  • Pull in expertise and resources locally and from the Safety network as needed; and likewise, catalyze Patient Safety Partners' strong contribution and engagement with the Safety NET as well as the wider Patient Safety Community. PtSL leads and/or contributes meaningfully to high-priority work in the Safety NET.

  • Lead and empower local self-organizing Patient Safety Partners to identify shared purpose with stakeholders and leveraging this to co-create solutions as well as unlock possibilities for patients through Safety.

  • Drive continuous improvement of local safety capabilities in operational PV and safety science expertise, including the ability to apply safety insights in the local context. Among others, this may include activities to enhance the safe use of Roche medicinal products, treatment outcomes, patient experience, effective safety communication, fit for purpose risk minimization, product launch support, product access, and generation of additional safety insights.

Who You Are

  • 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.

  • MD/ HCP qualification is not a prerequisite, however, profile & qualification must meet local expectations (laws, regulations, stakeholders demands, etc.). E.g. countries that require MD or HCP qualification for QPPV or QPPV-like roles.

  • Significant experience relevant to PV in an affiliate setting (ideally, at least 5 years).

  • Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development, clinical safety is considered advantageous.

  • Deep understanding of the local environment and proven abilities to develop important partnership internally and externally, including influencing of, and negotiating with key personnel in an affiliate.

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.

Roche is an Equal Opportunity Employer.

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