Patient Safety Partner

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The Position

Job Purpose

The Patient Safety Partner serves as the primary custodian of pharmacovigilance (PV) excellence within the local affiliate, ensuring all activities meet stringent industry benchmarks, global Roche standards, and local legislative requirements in India. By overseeing the implementation and maintenance of an efficient local PV system, this role safeguards the company's License to Operate and maintains a constant state of 100% inspection readiness. As a strategic bridge between global strategy and local execution, the Partner supports IPS and Affiliate's Patient Safety (APS) initiatives through decisive leadership, cross-functional collaboration, and high-quality solution delivery. Ultimately, through expert decision-making and proactive ownership, they ensure that patient safety remains an uncompromising priority and a core competitive advantage for the affiliate.

Key Responsibilities

Collaborates with key stakeholders, including Patient Safety Operations and Affiliate PV Net, to execute core pharmacovigilance activities. Ensures robust monitoring of product safety profiles and risk management strategies to maintain regulatory compliance and the license to operate, while proactively identifying system optimizations.

• 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, Managed Access Programs, Compassionate Use Programs, PTAP, DiCELAs)

  • Safety Labeling and PV Commitments

  • Local Pharmacovigilance System Master File

• Shape country-specific PV ecosystems and regulations according to APS groupings. Collaborate with key stakeholders - including pharma associations and patient groups - to champion regulatory reliance and advance international harmonization efforts

Local Safety Risk Management

• Identify, analyze and share safety insights by understanding disease areas - Drive the proactive integration of safety insights into regional and global strategies. This involves analyzing the Roche portfolio and patient pathways, engaging with key stakeholders, and translating complex safety data into strategic priorities for the Affiliate

• Drive safety launch readiness and the local execution of global safety solutions - Serve as the Safety Champion for Priority Disease Areas of the Affiliate, partnering with cross-functional teams to align safety strategies with broader therapeutic goals Thereby contributing towards launch readiness.

• Risk management and safety communication - Support country-level risk management and safety communication strategies in collaboration with Medical Affairs and key stakeholders. Responsible for the timely, compliant distribution of safety information (e.g., DHPCs) to healthcare professionals and patient groups to maximize therapeutic benefits and minimize risk

Quality Management System

• Regulatory Alignment: Ensure Affiliate PV System procedure(s) aligns with global PV procedures and complies with local and regional PV regulations.

• Quality Management: Manage PV non-conformances and CAPAs, utilizing root cause analysis techniques to lead investigations, document findings, and drive timely remediation.

• Data Integrity: Ensure data integrity across all safety systems, documentation repositories, and the Veeva platform to ensure inspection-ready data quality.

• PV training and oversight: Maintain oversight of the PV training plan and ensure training compliance with PV personnel, business partners, vendors, and affiliate staff in accordance with local requirements.

Maintain and Oversight of the Pharmacovigilance System

• Pharmacovigilance System Master File (PvMF or PSMF) - Prepare and maintain the PSMF. Ensure all local and regional sections are accurately maintained to support seamless regulatory audits and inspections.

• PV policy and Regulatory Compliance - Ensure that Affiliate PV processes, procedures and systems are in place to comply with Roche's Global PV procedures and with local and/or regional PV regulations.

Success Factors

• Extensive experience in operational risk assessment, quality issue management, root cause analysis, corrective and preventative action (CAPA) development and tracking and audit/inspection preparation.

• Knowledge of PV vendor management.

• Familiarity with global PV regulations (FDA, EMA, ICH).

• Experience in clinical trial and post-marketing PV.

• Strong communication, problem-solving, and organizational skills.

• Experience with SOP development, process review, and PV/clinical/regulatory documentation.

• Ability to map complex PV processes and manage document updates through quality systems.

• Experience with PV systems specifically ArisG, and Veeva Vault Safety.

Strategic Thinking & Planning - Understands the basics of strategic planning and its importance.Contributes to local strategy and ensures tactical actions align with broader organizational goals.

Proactive and Strategic Mindset - Demonstrates a proactive, system-thinking mindset to plan for long-term outcomes and adapt objectives in response to changing business needs.

Collaboration & Stakeholder Management - Demonstrates an abundance mindset, thinking beyond one s role and team to identify wider opportunities and impact

Problem Solving & Prioritization - Solves problems within own discipline and remove or reduce obstacles/barriers. Prioritizes own work in support of global and local priorities to create clarity and focus.

Knowledge & Learning - Maintains a solid understanding of drug development, commercial drivers, and regulatory requirements, integrating these into daily operations. Actively seeks and provides constructive feedback to drive personal development and team performance.

Qualifications

• Medical, pharmacy or life-sciences degree (or equivalent).

• Min 3 years experience working in the pharmaceutical industry in a pharmacovigilance role is required, with a scientific acumen and the ability to understand and apply scientific concepts effectively.

• Adequate theoretical knowledge and practical experience of PV activities and systems with sound understanding of the regulatory and PV monitoring requirements in India

• Sound judgment, strong planning and organizational skills, and the ability to get things done.

Who we are

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.