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Senior Patient Safety Partner
F. Hoffmann-La Roche GruppeKuala Lumpur, Kuala Lumpur, Malaysia21 jam yang lalu
Penerangan pekerjaanIndividual Case Safety Reports (e.g. data collection) Signal Detection & Signal Management for Local Products Aggregate safety reports (e.g. submission to Health Authority) Pharmacovigilance Agreements (e.g. PVA, Safety Data Exchange Agreement) Risk Management and Safety Communication (e.g., Direct Healthcare Professional Communication, Risk Minimization Measures, emerging safety issues) Studies, Programs and other projects with PV implications (e.g., ICT, NIS, PASS, PAES, MAP, PAA, CUP, PTAP, Dicela) Safety Labeling and PV Commitments (Local) Pharmacovigilance System Master File Shape country PV regulations and the broader country pharmacovigilance ecosystem according to APS grouping, particularly to promote regulatory reliance and international harmonization in partnership with local pharma industry associations, healthcare organizations, patient groups etc. (e.g. simplification of local implementation of aRMM together with trade associations and HA). Identify, analyze 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. Strengthen cross-functional and cross-country collaboration : Foster strong cross-functional partnerships and represent affiliate safety interests in IPS forums, strategically influencing cross-country initiatives and implementing global solutions into local clinical practice. Qualification and / or Degree in life science or healthcare-related discipline (e.g., PharmD, MSc, BSc, Nursing, etc.). At least 3-5 years experience in pharmacovigilance, ideally in an affiliate setting Decision-making ability in the local & global PV ecosystem Experienced in collaborating within global and local matrix environments, including proven ability in stakeholder management and influencing Advantage : Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical Safety
Overview
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Job Purpose
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.
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.
Key Responsibilities
PV 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, meeting regulatory requirements, and ensuring license to operate. Proactively identify opportunities to optimize the PV system.
Key areas of activities include the following in line with Roche standard operating procedures (where applicable) :
Local Safety Risk Management (according to APS grouping)
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).
Education / Qualifications
Experience
Who we are
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. 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.
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