Regional Center Partner

The Opportunity: This role is responsible for supporting Regional Center activities in accordance with internal processes and local and international regulatory requirements, and consistently delivering high-quality and compliant outcomes. The role also contributes to oversight of external vendors, and contributes to a high-quality, inspection-ready PV system across the assigned scope. As the Regional Center Partner (PV, Pharmacovigilance), you are responsible for: ● Ensures end-to-end collection, reporting and handling of safety information in compliance with Roche and local regulatory requirements within the assigned Regional Center coverage areas. ● Maintains robust oversight and performs safety risk management activities, including those executed by external vendors. ● Proactively manages workload and priorities to ensure regulatory timelines and quality standards are consistently met. ● Drives continuous improvement and simplification of processes to enhance efficiency and effectiveness ● Collaborate closely with PSO colleagues, Subject Matter Experts (SME),Country Champions, Affiliate Patient Safety and cross-functional stakeholders to ensure seamless execution and compliance ● Identify and escalate risks, gaps, or deviations related to Regional Center activities, and ensure appropriate follow-up actions ● Ensure accurate and compliant documentation and record management in line with Coremap requirements Key activities All of the key responsibilities outlined below are applied in context with global Roche and local legal requirements. I. Maintain a local PV system in context with and as defined in the wider global Roche PV system ● Ensure appropriate documentation of operational related information and activities. ● Ensure business continuity of critical PV systems, processes, and activities. ● Ensure inspection readiness at all times. II. Pharmacovigilance System Master File (PSMF) ● Where Regional Center is required to provide information and data relevant to the global Roche PSMF, or for other global PV oversight or management purposes, ensure the data is current, accurate, complete, and provided in a timely manner. Where a separate local PSMF is required, ensure consistency with global Roche processes for local PSMF or PSSF. (where applicable). III. Case Management ● Ensure timely, accurate, and compliant management of safety reports from all sources, including case intake, follow-up, assessment, reporting, and documentation ● Maintain high standards of quality and efficiency in safety data handling, in line with Roche processes, regulatory requirements, and internal scientific standards ● Provide oversight of activities performed by external vendors, ensuring adherence to defined requirements and timelines. IV. Management of aggregate reports ● Provide accurate and timely input to global functions for the preparation of aggregate safety reports, as required. ● Serve as Lead Author for safety-related documents, including Local Aggregate Report (LAR) and Domestic Periodic Benefit-Risk Evaluation Report (PBRER) for medicinal products and medical devices. ● Contribute to development of Addendum of Clinical Overview (aCO) with key Partners. ● Perform analysis of local/regional safety data in accordance with regulatory requirements to support benefit-risk evaluation and reporting V. Risk management and safety communication ● Contribute to the development of local Risk Management Plans (RMP) and ensure oversight of RMP implementation and safety communication, including adequate documentation of risk minimization activities, dissemination of communication and activities, decisions, and actions taken as applicable. (where applicable). VI. Oversight of studies, programs, and other business activities ● Ensure appropriate safety reporting and oversight processes are in place for studies (including interventional clinical trials, NIS, PASS, PAES), Market Research and Patient Support Programs (MAPs), pre-approval and post-trial access programs (including 'compassionate use'), Digital Channels and all other business activities with implications for PV compliance. ● Maintain oversight of external third parties acting on behalf of Roche (e.g., service providers, CROs) or acting as Roche business partners (e.g., distribution, licensing, or development partners), ensuring adherence to regulatory requirements and ongoing monitoring of performance and compliance. ● Perform execution of Safety Notification Process related r…