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Drug Safety Coordinator

Integrated Resources, Inc

Florham Park, New Jersey

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Adverse Events, Biotech and Pharmaceutical, Clinical Information, Clinical Laboratory, Clinical Research, Clinical Trial, Communication Skills, Data Entry, Database Technology, Documentation, Healthcare, Information Technology & Information Systems, Interpersonal Skills, Marketing, Medical Dictionary for Regulatory Activities (MedDRA), Nursing, Organizational Skills, Pharmacovigilance, Process Management, Regulations, Regulatory Reports, Regulatory Requirements, Rehabilitation Nursing, Safety Process, Safety Systems, Standard Operating Procedures (SOP), Time Management
LOCATION
Florham Park, New Jersey
POSTED
1 day ago
Drug Safety CoordinatorA 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 DescriptionSeeking 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 reportsPerforming active follow-up via verbal or written contact with healthcare professionals (MDs, RNs, etc.) and consumersCoding verbatim AE terms, medical history, laboratory data, and drugs using MedDRA and WHO-Drug dictionariesReconciliation of safety information received from external organizations, exchanged with corporate partners, and obtained from clinical trialsTrain other department staff regarding handling of safety information as neededAssist in compiling regulatory reports (e.g., PADER).Perform other duties as required.QualificationsBachelor'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.

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Integrated Resources, Inc

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