Safety Information Specialist - Temp

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Location

Ardsley, NY, United States

Summary

The Safety Information Specialist Temp is responsible for activities related to intake and distribution/submission of Individual Case Safety Reports (ICSR) according to reporting requirements. In addition, this individual monitors case processing workflow and internal timelines to ensure regulatory and contractual compliance.

Full Description

The Safety Information Specialist Temp is responsible for activities related to intake and distribution/submission of Individual Case Safety Reports (ICSR) according to reporting requirements. In addition, this individual monitors case processing workflow and internal timelines to ensure regulatory and contractual compliance.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Manages incoming electronic mailbox through which most safety and reportable information is received.
  • Makes inbound letters received from consumers, healthcare professionals, and other manufacturers available in the central repository.
  • Reviews source documentation for completeness and accuracy, and obtains clarification from external service providers as needed.
  • Performs duplicate searches and enters safety information related to Individual Case Safety Reports (ICSR) in the ARGUS database.
  • Performs safety data reconciliation with Call Center, Business Partners, and other service providers.
  • Performs initial data entry of safety information not requiring medical assessment/interpretation (which may include reporter contact details, medical history, concomitant medications and lab results) for ICSRs from clinical trials and post-marketing sources.
  • Performs electronic submissions and distributions of ICSRs to FDA and licensing partners.
  • Completes, tracks, and documents due diligence activities (outbound follow-up letters) for post marketing reports requiring additional information and/or clarification.
  • Monitors workflow and case processing timelines of ICSRs to maintain regulatory and contractual compliance.
  • Uploads to ARGUS database as needed, documents related to ICSR case processing to support the maintenance of comprehensive electronic case files.

Education and/or Experience:          

  • High School Diploma required.
  • Bachelor’s degree preferred.
  • Minimum of 1-3 years drug safety experience in ICSR case processing preferred.
  • Prior experience in a biotechnology or pharmaceutical company preferred.
  • Familiarity with the following: safety databases, data entry platforms, adverse event data collection process, case processing unit, call center, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development.

Qualifications:

  • Basic knowledge of cGXPs.
  • Working knowledge of Demonstrated Good Documentation Practices.
  • Working knowledge of medical terminology.

Computer Skills:

  • Must be proficient in MS Office Suite.

Certificates, Licenses, Registrations: None required.

Other Skills and Abilities:

  • Excellent written and verbal communication skills.
  • Ability to interpret and follow regulatory guidelines.
  • Ability to manage both day-to-day operations as well as project work in a fast paced environment.
  • Ability to work both independently and in a collaborative team setting.
  • Must demonstrate a keen attention to detail and timelines.
  • Ability to maintain a high level of ethical and compliancy standards.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • There is minimal travel for this position; the average travel is 5-10% with some variation based upon the demands of the business imperatives.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.