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Roche Pharmaceuticals

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 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.

Key areas of activities include the following in line with Roche standard operating procedures (where applicable): 

Individual Case Safety Reports (e.g. data collection and reporting to HA)

Signal Detection & Signal Management for Local Products 

Aggregate safety reports (e.g. data collection and submission to HA)

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, 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: 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 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).

Education/Qualifications 

Qualification and/or Degree in life science or healthcare-related discipline (e.g., PharmD, Pharmacy, Nursing, Medicine, Master of Science, Bachelor of Science, etc.).

Experience

1-3 years 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 on local  projects

Focuses on the basics of execution: can understand project fundamentals, contribute to plans, manage their own tasks, communicate basic information, and recognize potential issues, solve problems, and report progress comprehensively.

Collaboration & Stakeholder Management

Actively contributes ideas and expertise to network 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

Abundance mindset, thinking beyond one's role and team and looking at wider opportunities and impact

Problem Solving and Prioritization

Solves problems within own discipline and removes obstacles

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 

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

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.