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.