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 guidelines and act as a contact person within the affiliate.

* Responsible for ensuring compliance with Ministry of Health/Regulatory Authority (MoH/RA) requirements and GPS policies, procedures, and processes.

Serve as the point of contact for the receipt and collection of AE ...