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The Position

Job Purpose

Drive 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.

Drive 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

• Operational excellence in the 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 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

• 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: Drive 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.

• Strengthen cross-functional and cross-country collaboration: Foster strong cross-functional partnerships and represent affiliate safety interests in IPS forums strategically influencing cross-country initiatives and implementing global solutions into local clinical practice.

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 MSc BSc Nursing etc.).

Experience

• At least 3-5 years experience in pharmacovigilance ideally in an affiliate setting

• Decision-making ability in the local & global PV ecosystem

• Experienced in collaborating within global and local matrix environments including proven ability in stakeholder management and influencing

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

Who we are

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.