Patient Safety Partner

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.

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 & Affiliates 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 ones 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

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.