La 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
Roche est un employeur offrant l'équité en matière d'emploi.
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