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The purpose of the role is to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance (PhV) in aligned countries. In the absence of the primary PhV role, the PhV backup shall take up key responsibilities.

Descripción

• Execute pharmacovigilance activities as nationally required (such as adverse event management, expedited and periodic reporting).
• Responsible for appropriate communication between local product safety, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical affairs, and regulatory affairs).
• Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise awareness of PhV, as required.
• Strive for inspection and audit readiness, and participate in aligned affiliate inspections, audits, and assessments.
• Help interpret relevant regulations and guideli...