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As a Pharmacovigilance Associate and Country Safety Head Backup, you will support pharmacovigilance activities in Israel and serve as backup to the Country Safety Head and QPPV, ensuring continuous compliance with local and international pharmacovigilance regulations while maintaining the highest standards of patient safety.
Your key responsibilities will include monitoring diverse safety information sources to ensure timely detection and appropriate management of incoming pharmacovigilance data, assisting in the overall evaluation of pharmacovigilance information, and reporting safety related information to relevant stakeholders including Health Authorities. You will support local safety surveillance activities, including the management of safety signals and assessment of new safety information, and support to risk management activities.
You will serve as the designated backup to the Country Safety Head (CSH) and QPPV, ensuring continuity of pharmacovigilance operations and regulatory compliance during absences. In this capacity, you will maintain Israel's primary pharmacovigilance contact relationship with Health Authorities and provide support for strategic safety leadership when required.
Main responsibilities:
Ensure accurate and timely management of pharmacovigilance data including individual case reports, aggregate reports, any PV administrative tasks, local literature monitoring, reconciliation and quality checks.
Assess safety data to identify trends , potential safety observations, and potential signals; notify new safety information to local Health Authority and/or respond promptly to corporate and Health Authority queries.
Ensure local pharmacovigilance activities comply with PSPV policies, global /local PV regulations and all processes and data are always inspection and audit ready.
Support risk management activities and implementation of risk minimization measures in coordination with relevant stakeholders.
Maintain and update PV procedures in line with current regulations and global company policies, supporting training, compliance activities, and corrective and preventative actions.
As designated backup to the Country Safety Head/QPPV, ensure continuity of pharmacovigilance operations and regulatory compliance during absences, including maintaining Health Authority contact relationships and supporting strategic safety leadership when required

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