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Clinical/Regulatory - Safety Review Specialist
Ref No.: 17-00308
Location: Bannackburn, Illinois
Start Date: 05/05/2017
Duration: 12 Months
Bannockburn, IL

This position is a member of the Safety Operations team within Global Pharmacovigilance and serves as a case owner for adverse events to ensure timely and accurate review, processing, and reporting.

Responsibilities include, but are not limited to the following:
*May perform initial triage of source documents for duplicate check within the Global Safety Database, case priority, Awareness Date, and closure/submission timeline.
Review source documents for accuracy of triage assessment to include case priority, Awareness Date and internal and external completion/submission dates
*Perform initial safety review of adverse events to determine seriousness, expectedness, reporter's causality, and overall event resolution.
*Ensure that the correct suspect drug was selected within the Global Safety Database
*Write narratives summarizing all relevant medical information for individual case safety reports

*Code medical terms using standardized medical dictionaries (such as MedDRA)
*Using expertise in therapeutic area, ensure that data has been entered and coded correctly by data coordinators and medical reviewers
* Request case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters in conjunction with local affiliates

*Take initiative to recognize, prioritize and escalate potential safety/ compliance issues
*May participate in risk assessments and signal detection activities for therapeutically aligned products
*Interact with other GPV functional areas to process adverse events efficiently and reliably.
*Collaborate with relevant counterparts in the regional and country Pharmacovigilance functions to facilitate the global exchange of safety information

*Interface with other groups (e.g. Quality, Regulatory, IT, Legal, business units, etc)
*May participate in literature review activities related to adverse event reporting with oversight from Literature Team reviewers
*Perform Source Verification quality checks as requested/necessary.
*Serve on departmental committees and projects as needed
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
*Medical & clinical knowledge
*Excellent analytical & problem solving skills
*Excellent oral & written communication & interpersonal skills
*Operates effectively in a team environment
*Ability to work under strict deadlines and changing priorities with some supervision
*Able to multitask and prioritize changing workload on a daily basis
*Working knowledge of ICH guidelines and other worldwide safety regulations
*Ability to establish priorities and proceed with accomplishing objectives
* Ability to establish proficiency working with a Global Safety Database
*Exposure to relationships with regulatory authorities

*Strategic Planning and Problem Solving: Work with next level management to plan and implement processes.
*Product/Process Quality Standards: Maintain currency and compliance with regulatory procedures and systems
*Risk Assessment and Contingency Planning: Facilitate the identification of risk elements for specific projects to get early indication of areas of risks

Include the education and experience that is necessary to perform the job satisfactorily.
*Bachelor's Degree in nursing or Bachelor's degree in pharmacy or equivalent
*Experience in pharmaceutical industry; Safety or Regulatory department preferred
*2-3 years hospital, patient care, or equivalent experience preferred