Pharmacovigilance Associate

Pharmacovigilance Associate

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

Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports

Carry out case processing activities

Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments

Review case criteria to determine the appropriate workflow for case processing

Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately

Write and edit the case narrative

Determine and perform appropriate case follow-up, including generation of follow-up requests

Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios.

Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation

Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database

Determine reportability of scheduled reports, ensuring adherence to regulatory requirements

Consistently apply regulatory requirements and policies

Participate, as appropriate, in local, internal and external safety activities.

Qualifications

Experience in pharmacovigilance and/or data management preferred but not required

Experience and skill with medical writing an advantage

Demonstrated computer literacy

Experience in use and management of relational databases preferred

Health Care Professional or equivalent experience preferred

Ability, with supervision, 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.