Patient Safety Partner

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

Job Purpose

Support 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.

Support 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

• Execution of safety\-related activities relevant to the PV (Pharmacovigilance) 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):

• Individual 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


• As a contributor, 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 (including but not limited to) local pharma industry associations, healthcare organizations, patient groups etc. (e.g. simplification of local implementation of aRMM together with trade associations and HA).

Local Safety Risk Management (according to APS grouping)

• 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: Support 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:

Education/Qualifications

• Qualification and/or Degree in life science or healthcare\-related discipline (e.g., PharmD, MSc, BSc, Nursing, etc.).

Experience

• Proven experience in pharmacovigilance, ideally in an affiliate setting


• Understanding of decision\-making in the local\& global PV ecosystem


• Advantage: Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical Safety

Competencies

Strategic Thinking\& Planning

• Understands the basics of strategic planning and its importance.


• Pro\-active and strategic mindset; able to think in systems and plan for outcomes.


• Is able to update own and team objectives/actions to reflect changing circumstances and to influence strategy for local projects


• Focuses on the fundamentals of execution, including understanding project basics, contributing to plans, managing personal tasks, communicating essential information, identifying and resolving potential issues, and comprehensively reporting progress.

Collaboration\& Stakeholder Management

• Actively contributes ideas and expertise to local and above country projects.


• Shares experiences and best practices that benefit the network


• Influence to gain support for initiatives from cross\-functional teams.


• Understands the structure, key roles and responsibilities of internal stakeholders and builds trusting relationships


• Communicates timely and effectively


• Demonstrates an abundance mindset, thinking beyond one's role and team to identify wider opportunities and impact

Problem Solving and Prioritization

• Solves problems within own discipline and removes or reduces obstacles/barriers


• Prioritizes own work in support of global and local priorities to create clarity and focus.

Knowledge\& Learning

• Ability to seek information to understand high level drug development


• Basic understanding of drug development, pharmaceutical industry, commercial development, and financial standing.


• Understands regulatory requirements and integrates them into daily activities.


• Can clearly speak about process during an audit or inspection


• Seeks feedback on their performance and grows confidence in providing appropriate feedback to others

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100\.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik\-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

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