Job PurposeSupport 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 ResponsibilitiesPV SystemExecution 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 ProductsAggregate 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 FileAs 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).Act 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 local pharma industry associations, healthcare organizations, patient groups etc.Who you areEducation/QualificationsQualification and/or Degree in life science or healthcare-related discipline (e.g., PharmD, MSc, BSc, Nursing, etc.)ExperienceProven experience in pharmacovigilance, ideally in an affiliate settingUnderstanding of decision-making in the local & global PV ecosystemAdvantage: Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical SafetyCompetenciesStrategic Thinking & PlanningUnderstands the basics of strategic planning and its importancePro-active and strategic mindset; able to think in systems and plan for outcomesIs able to update own and team objectives/actions to reflect changing circumstances and to influence strategy for local projectsFocuses 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 progressCollaboration & Stakeholder ManagementActively contributes ideas and expertise to local and above country projectsShares experiences and best practices that benefit the networkInfluence to gain support for initiatives from cross-functional teamsUnderstands the structure, key roles and responsibilities of internal stakeholders and builds trusting relationshipsCommunicates timely and effectivelyDemonstrates an abundance mindset, thinking beyond one's role and team to identify wider opportunities and impactProblem Solving and PrioritizationSolves problems within own discipline and removes or reduces obstacles/barriersPrioritizes own work in support of global and local priorities to create clarity and focusKnowledge & LearningAbility to seek information to understand high level drug developmentBasic understanding of drug development, pharmaceutical industry, commercial development, and financial standingUnderstands regulatory requirements and integrates them into daily activitiesCan clearly speak about process during an audit or inspectionSeeks feedback on their performance and grows confidence in providing appropriate feedback to othersRoche is an Equal Opportunity Employer.
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