Local Pharmacovigilance Responsible (Deputy LPV)

Responsibilities

• Support the implementation and maintenance of the local pharmacovigilance system in accordance with global and local regulatory requirements.
• Manage and process adverse event reports and other pharmacovigilance cases from all sources in compliance with internal procedures and reporting timelines.
• Conduct local literature reviews and ensure appropriate processing of safety information identified through literature monitoring.
• Support local signal detection activities and communicate potential safety signals to Global Safety.
• Maintain oversight of safety reporting activities related to clinical studies, non-interventional studies, and patient support or compassionate use programs.
• Provide local safety information for periodic safety reports and ensure local regulatory submissions are completed as required.
• Support the implementation and monitoring of Risk Management Plans (RMPs) and additional Risk Minimization Measures (RMMs).
• Coordinate responses to safety-related inquiries from regulatory authorities and support safety communications to healthcare professionals and consumers.
• Contribute to local labeling updates and implementation of safety-related regulatory commitments.
• Maintain the local pharmacovigilance quality system, including training, compliance monitoring, documentation, and record management.
• Participate in the establishment, maintenance, and oversight of pharmacovigilance agreements with third-party partners and service providers.
• Support business continuity planning to ensure uninterrupted pharmacovigilance operations.
• Monitor changes in local pharmacovigilance regulations and assess their impact on local processes.
• Act as a key contact during pharmacovigilance audits and inspections and support the implementation of corrective and preventive actions (CAPAs).
• Promote a culture of patient safety, regulatory compliance, and pharmacovigilance awareness across the organization.