Drug Safety Specialist

  • location: Philadelphia, PA
  • type: Contract
  • salary: $70 - $90 per hour
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job description

Drug Safety Specialist

job summary:
The Drug Safety Specialist (with a focus on QC) is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations and standard operating procedures and guidelines. The Drug Safety Specialist will perform accurate computer data entry of identified adverse event information and ensure the uniform and timely processing and reporting of adverse events to regulatory authorities.

The Drug Safety Specialist will be responsible for performing quality review of individual case safety reports and for providing feedback to team members, working closely with the case processing team and Medical Reviewers to ensure complete and accurate information has been entered into the safety database.

location: Philadelphia, Pennsylvania
job type: Contract
salary: $70 - 90 per hour
work hours: 9 to 5
education: Bachelors
  • Performs quality control activities including Oversight QC to ensure complete and accurate case information has been entered into the drug safety database, and provides feedback to team members
  • Helps monitor the QC workload to ensure compliance with business partner and regulatory requirements
  • Helps identify areas for process improvement (specifically regarding quality) and possible areas for retraining for individuals/team
  • Processes adverse event information received by the Team and assists in the preparation of internal and external reports
  • Reviews case information for appropriate distribution to internal and external business partners
  • Performs accurate computer data entry of identified adverse event information and ensures the uniform and timely processing and reporting of adverse events to regulatory authorities
  • Reviews adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management, and independently generates narratives in accordance with department processes
  • Follows company processes and guidelines for case management and closure activities
  • May triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of Team management
  • May distribute completed regulatory reports to RA, ClinOps and other as needed to meet regulatory reporting timelines
  • May participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures
  • Adheres to company templates and guidelines for documentation and communications
  • Ensure compliance with corporate and departmental standard operating procedures
  • As an individual contributor, may serve as a project manager for functional projects or workflows
  • Preferred health care professional background, either nurse or PharmD and a minimum of 3 years drug safety experience, or
  • BS/BA degree in a health related or biological science related field and 5 years of drug safety experience, or
  • Minimum of 7 years of drug safety experience.
  • Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
  • Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
  • Experience in safety case processing as well as quality review of individual case safety reports, both in-process and via sampling, is preferred
  • Experience with preparation of investigational and post-marketing regulatory reports
  • Proficiency in standard desktop software programs (Word, Excel, Outlook) Experience using Argus other safety database applications
  • Experience using MedDRA
  • Excellent oral and written communication skills
  • Highly organized and demonstrates consistent attention to detail
  • Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills
  • Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
  • Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
  • Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment
skills: Argus, AD (Adverse Events)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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