Job Snapshot
Location:
Durham, NC 27713
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Industry:
Healthcare - Health Services
Pharmaceutical
Job Type:
Health Care
Pharmaceutical
Nurse
Experience:
Not Specified
Description
Drug Safety Alliance (DSA), located in Research Triangle Park, N.C. is seeking a talented Drug Safety Case Manager. DSA is a full-service outsourcing provider with an exclusive focus on drug safety. Our clients are large, midsize, and emerging pharmaceutical and biotechnology companies, both domestic and international. We support over 500 pharmaceutical and biological products internationally. DSA effectively manages a suite of services including case management, regulatory consulting, quality management, and a secure, validated safety database.
SCOPE:
Coordinates and participates in activities relating to the collection, triage, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds.
RESPONSIBILITIES:
· Collect and process incoming adverse event data from client call centers as well as interact with reporters and clients as necessary to obtain clarification or follow-up information.
· Extract and validate adverse event data from various clinical trial cases and spontaneous sources including health professionals, consumers, sales representatives, drug information, legal, and literature.
· Data enter all case-related information including initial interpretation of medical conditions, lab results and procedures as well as draft complete narrative summaries.
· Ensure the timely submission of reports to worldwide regulatory agencies in accordance with applicable regulations.
· Ensure that all inquiries from FDA for additional case information or clarification (telephone and written) are responded to in a timely and appropriate manner.
· Respond accurately and appropriately to inquiries from health care professionals, consumers, and client company personnel regarding safety issues with marketed products.
· Ensure proper coding of AE terms (MedDRA) into adverse event global database.
· Perform searches of the adverse event database for internal compliance and labeling purposes.
· Review, enter and verify follow-up information from spontaneous sources and clinical investigations.
· Analyze and extract data from literature sources.
· Other duties as assigned.
QUALIFICATIONS:
· Bachelor’s degree in a nursing or scientific field. Health care professional (HCP) or pharmaceutical industry experience is preferred.
· Proficiency in MS Office and previous database experience preferred
· Knowledge of medical terminology strongly preferred
· Ability to work as a team member and independently in an environment of rapidly changing priorities; manage multiple projects and a large volume of assignments
· Manage and organize work to meet strict timelines
· Communicate effectively in English, both verbally and in writing
· Maintain and protect client, patient and corporate confidentiality
· Able to interpret DSA and client specific SOP’s and WP’s
· Assimilate and analyze large quantities of medical data from clinical trials and post-marketing experience
· Utilize sound decision-making skills to solve problems and troubleshoot /issues in the area of expertise and job assignment
· Attention to detail; ability to assess and follow algorithms and workflow diagrams with timelines and notification details
Drug Safety Alliance offers competitive compensation, an attractive benefits package, the opportunity for professional advancement, and career growth. If you meet the position requirements and are seeking an opportunity to contribute in a dynamic, small company environment, please submit a resume and salary history to email your resume to: [Click Here to Email Your Resumé] Drug Safety Alliance is an Equal Opportunity Employer.
No agency calls please.
