Drug Safety Assistant

Drug Safety Assistant

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.

• Execution of local activities relevant to the management of safety data.

• Monitor and manage dedicated DSU mailboxes

• Maintain local documentation as required by legislation (including archiving/tracking/retrieval) – lifting of boxes

• Support the submission and distribution of reports and relevant tracking

• Support distribution and tracking of distribution of Follow-Up letters

• Support inspection preparedness activities policies and practices as per Company SOPs

• Consistently apply Archiving policies as per Company SOP.

• Basic understanding of Pharmacovigilance

• Demonstrated computer literacy

• At least 2 years' experience in the use and management of relational databases

• Ability to solve routine problems and to surface issues constructively

• Ability to make basic decisions with an understanding of the consequences

• Ability to achieve personal objectives while meeting departmental standards of performance

• Ability to work under supervision in a matrix organization

• Fluency in spoken and written English.

• Candidate must have a 4 year degree.

• Manager is seeking candidates with 1-3 Years Drug Safety Experience

• 1-3 years of regulatory experience required