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The Patient Safety Partner supports/ drive the implementation, maintenance and oversight of the local PV system for the assigned affiliate(s)/country(ies), to ensure an efficient and effective PV system that complies with global Roche and local legal/regulatory authority PV requirements, safeguarding our License to Operate. The Patient Safety Partner supports/ drive the execution of IPS & Affiliate’s Patient Safety (APS) strategies, ensuring high-quality implementation of global and local safety solutions, while demonstrating leadership in ownership, collaboration, and decision-making within assigned responsibilities. Note: This role be responsible for Malaysia and will also be supporting the country cluster.

Key Responsibilities:

Pharmacovigilance System

Operational excellence in the execution of safety-related activities relevant to the PV system through partnership with key stakeholders such as Patient Safety Operations and Affiliate PV Net, to ensure monitoring of the safety profile of Roche products and their safety risk management, meet regulatory requirements, and ensure license to operate. Proactively identify opportunities to optimize the PV system.

Shape country PV regulations and the broader country pharmacovigilance ecosystem according to APS grouping, in particular in order to promote regulatory reliance and international harmonization in partnership with, and not limited to, local pharma industry associations, healthcare organizations, patient groups etc, where applicable. 

Local Safety Risk Management

Generate and share safety insights by understanding disease areas (Roche portfolio, patient journey), engaging with key stakeholders, and ensuring timely, proactive integration into Affiliate and global strategies.

Implementation of safety solutions and launch readiness activities: Implement global safety solutions locally within the integrated therapeutic strategy, and execute product safety launch readiness activities.

Risk management and safety communication: Drive the country-level risk management strategy to optimize patient outcomes in collaboration within relevant networks and ensure compliant and transparent PV communications (e.g., DHPCs) to healthcare professionals, patients, and external partners in collaboration with Medical Affairs and the cross-functional team.

Further responsibilities may include assuming additional roles (e.g. RMP IC, core or extended member of the Affiliate Safety Disease Area Communities (ASDACs), Safety Responsible for MAP and DiCELA, Disease Area Expert, PV System Expert).

Who You Are

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

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. 

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.