Job Details
Posted 15 May, 2026
Job Id: 628010
Case Management – Sr Associate
Job Description
Target PR Range: 19-26/hr DOE
Purpose:
To support the safety surveillance process for 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 safety database usage (preferably in Lifesphere Multivigilance by ArisGlobal) and medical coding. Comprehensive English writing skills. Excellent phone conversations skills. Comprehensive knowledge on MS Office applications.
Basic qualifications:
Masters degree
OR
Bachelors degree and 2 years of [Job Codes Discipline and/or Sub-Discipline] experience
OR
Associates degree and 6 years of [Job Codes Discipline and/or Sub-Discipline] experience
OR
High school diploma / GED and 8 years of [Job Codes Discipline and/or Sub-Discipline] experience
*CO/NYC candidates might not be considered
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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