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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Sr. Assoc., Pharmacovigilance Operations (Case Management - Sr Associate)
Remote, CA US
Posted: 07/08/2025
2025-07-08
2025-08-11
Employment Type:
Contract
Job Category: Pharmacovigilance (PV)/Drug Safety
Job Number: 4514
Job Description
Support the safety surveillance process for the client's 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.
Responsibilities:
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.
Responsibilities:
- 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).
- Bachelor's degree and 2 years of directly related experience OR Associate's degree and 6 years of directly related experience
- 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.
- Case Management vendors, GQM/BPO, SOPS, MSRT, LSOs, Business Partners.