I seek a senior level Drug Safety Case Manager for a Durham, NC. This position would be responsible for case processing position responsible for triaging, entry, and case finalization for complex cases requiring subject matter expertise for two or more clients/therapeutic areas. This position is also responsible for providing quality customer service including robust communication and prompt follow-up to client queries.
Extract, analyze, and process adverse event data from all sources for multiple therapeutic areas and multiple clients.
Manage case reports for multiple clients in multiple databases on a daily basis.
Evaluate and integrate all case-related information including medical conditions, lab results and procedures as well as compile complete narrative summaries and queries.Apply knowledge of global regulatory requirements to complex cases to ensure the timely submission of accurate and comprehensive reports to worldwide regulatory agencies in accordance with applicable regulations.
Interact with reporters, sites, and clients as necessary to obtain clarification or follow-up information and assure that additional data is appropriately integrated into the ICSR and submitted to regulatory agencies.
Perform searches of the adverse event database for internal compliance and labeling purposes.
Respond accurately and appropriately to inquiries from clients using multiple channels to ensure that client satisfaction is attained.
This position may be required to perform a range of operational support activities including audit preparation, quality review, training, and mentorship. The senior case manager is expected to identify efficiency gaps and propose and implement tactical solutions and to assist the Operations Manager in evaluating resource capacity. This position also participates in the planning and execution of complex projects and assists in the development of Standard Operating Procedures (SOPs) and Working Practices (WPs).
Bachelor's degree (healthcare, nursing or life science degree preferred) with at least 3 years of experience to include working in a hospital or clinical environment and/or experience in a similar role at a pharmaceutical or biotech company, or contract research organization, or equivalent combination of experience and education
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About Advanced Recruiting Partners, LLC
Advanced Recruiting Partners (ARP) is a premium staffing agency dedicated to serving companies in the biopharmaceutical and life science industries. Established in 2009, our company is certified women-owned by the Women’s Business Enterprise National Council (WBENC) and has grown exponentially each year to meet the needs of customers and candidates nationwide.
ARP offers concierge-style customer service, flexible placement options and a broad selection of industry candidates. Our company’s owners possess more than thirty years combined industry experience.