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Drug Safety Associate
Research Triangle Park, NC 27709 United States
Drug Safety Associate is an entry level case processing position responsible for case assessment, data entry, and completion of Individual Case Safety Reports (ICSRs).This positions is also responsible for tracking operational metrics, providing client service support, and ensuring quality work product. Case Management duties may be related in the following areas: Over the Counter (OTC) Products, Prescription Medications, Investigational Products, Medical Devices or Animal Health.
Bachelor's degree (healthcare, nursing or life science degree preferred) with at least 1 year of experience working in a hospital or clinical environment, a pharmaceutical, biotech or animal health product development company, a contract research organization, or equivalent combination of experience and education.
Knowledge, Skills and Abilities:
Knowledge of drug therapy, disease states and pharmacokinetics. A working knowledge of FDA and international reporting regulations in addition to a basic knowledge of coding dictionaries such as MeDRA or VeDRA. Self-motivated and able to work effectively in an environment of rapidly changing priorities, manage multiple projects, and assimilate large quantities of data. Ability to work independently and as a member of a team and to successfully manage and organize work to meet strict timelines. Communicate effectively in English, both orally and in writing. Maintain and protect client, patient and corporate confidentiality. Utilize sound decision-making skills to organize and prioritize work by assessing and following algorithms and workflow diagrams with timelines and notification details. Efficient data entry skills; proficiently utilize MS Office software products and other required software. A substantial level of supervision is needed for this role.
North Carolina Biotechnology Center