Drug Safety Coordinator

Drug Safety Coordinator

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Seeking dynamic, focused and creative individuals to join our growing team. Looking for experienced pharmaceutical professionals to help us build for the future. Will be responsible for several portions of the adverse event case processing workflow including but not limited to receipt, evaluation, registration, partial data entry, documentation, and reporting of adverse event information from Clinical trial and post-marketing adverse event cases in accordance with company SOPs and US and worldwide regulations.

Duties & Responsibilities-

Entry of AE information into the safety database, executing database queries and reports. Performing active follow-up via verbal or written contact with healthcare professionals (MDs, RNs, etc.) and consumers. Coding verbatim AE terms, medical history, laboratory data, and drugs using MedDRA and WHO-Drug dictionaries. Reconciliation of safety information received from external organizations, exchanged with corporate partners, and obtained from clinical trials. Train other department staff regarding handling of safety information as needed. Assist in compiling regulatory reports (e.g., PADER). Perform other duties as required.

Qualifications

Bachelor's degree. (In healthcare related field or with nursing background is ideal). Strong interpersonal skills. Strong process management and communication skills. Working knowledge of drug safety reporting procedures and both US and international regulatory requirements. Ability able to work both independently and under supervision to accomplish objectives within deadlines. Minimum of 2 years' experience in drug safety. Experience with safety database systems; Argus and MedDRA coding experience is ideal.