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职位概要 Job Highlights：
职责描述 Key Accountabilities：
1. Manage collection/ processing/documentation/ reporting of all adverse event reports to CSPV for products from clinical trials, non-interventional studies, literature, Spontaneous Reports, etc.
2. Manage reporting/submission/distribution of safety reports /information (e.g. SAE, SUSAR,) to Local Health Authorities and/or clinical operations.
3. Oversees safety service vendors to ensure vendor’s output is consistent with company needs, expectations, and contractual obligations.
4. Interact and exchange relevant safety information with third-party contractor, if applicable.
5. Develop, update and implement local ICSR related procedures to ensure compliance with Patient Safety global procedures and national requirements.
6. Perform reconciliation with other departments for potential AEs resulting from medical inquiries, quality related complaints and other sources.
7. Management and maintenance of Patient Safety databases.
8. Prepare reports on ICSR compliance in a timely manner
9. Support on periodic safety reports related activities
10. Establishes and maintains effective relationships with partners regarding collaboration, project execution, and process-related issues.
11. Supports quality assurance activities for the consistency and quality of the pharmacovigilance process.
12. Contributes to audit/inspection readiness for pharmacovigilance activities.
13. Involve in identification and selection of candidates for the relevant Drug Safety & Pharmacovigilance positions. Provide mentoring and training to the department and within the company as needed.
职能需求 Competence Profile：