Job Description

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Purpose:
To support the safety surveillance process for Amgen products by performing follow up activities with patients and HCPs of individual case safety reports. Ensure vendor compliance with approved processes and training requirements. Oversee case quality of US ICSRs (CT and PM) including analysis and reporting of trends in quality measures. Point of accountability for managing one or more key vendor relationships for ICSR processing. Case processing point of contact for case related activities with assigned business partners. Case processing point of contact for audit related activities related to case processing. Accountable for measuring quality against contractual safety agreements. Accountable FDA point of contact for ICSR reporting. Submission of all individual safety reports to FDA, EMA and Business Partners.

Key Activities - Perform case review. Support the development and delivery of convention-related training material. Ensure compliance of reporting activities with timelines and criteria. Interface with local office staff, CROs and business partners for case processing issues as necessary. Provide E2B submission support (nullification, redistribution). Address case-related queries from Business Partners. Support antibody re-testing coordination (non-LAO tasks for repeat testing).

Knowledge and Skills - Understanding of global regulatory requirements for pharmacovigilance. Familiarity with clinical development processes . Case processing experience. Attention to detail. Competence in Argus safety systems and medical coding. Comprehensive English writing skills. Excellent phone conversations skills. Comprehensive knowledge on MS Office applications.

Key Relationships - Case Management vendors, GQM/BPO, SOPS, MSRT, LSOs, Business Partners.

Education & Experience (Basic) - Bachelor's degree and 2 years of directly related experience OR Associate's degree and 6 years of directly related experience

Job Tags

Remote job, Contract work, Local area,

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