Drug Safety Associate

Title: Senior Associate, Case Management (Drug Safety)
Contract role
Fully remote

Ideal:
Prior pharmacovigilance experience or exposure and 1-2 years of experience is required.

Purpose:
• To support the safety surveillance process for client 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.

Company DescriptionFounded in 1998 and located in Cranberry Twp., PA. SSi People is an organization with extensive staffing industry experience within several labor verticals throughout the United States for Fortune 1000 companies.

Whether you’re a company looking for talented people to fill demanding positions or a skilled professional looking for the right company to work with and build a career, the search can seem endless.

In today’s fast paced, get-it-done-yesterday world of business, it’s become harder than ever for the right people and the right companies to come together. Opportunities and qualified people often miss
each other, so the search goes on.

At SSi People, our job is to end the search. We connect companies to talent. It’s not easy, but it’s what we do best.