Deviation Specialist - Drug Safety

  • location: Philadelphia, PA
  • type: Contract
  • salary: $55 - $65 per hour
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job description

Deviation Specialist - Drug Safety

job summary:
  • To support case management team members with the completion of deviations and associated action Items.
  • Develop metrics and analysis relating the reasons for late closure within the case management team and put in place CAPA actions to remediate ongoing late closure of deviations and action items.
  • To liaise with the PV and Quality teams to align processes and expectations for CAPA actions and develop and deliver training of these expectations to the case management team.
  • Develop a tracking and escalation methodology within case management to enable quicker identification of potential late deviations.
 
location: Philadelphia, Pennsylvania
job type: Contract
salary: $55 - 65 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Work with the case management team who have deviations to ensure closure within the required time frame.
  • Work with case management to develop procedures for early identification of potential delays in the closure of deviations and associated action items
  • Develop and deliver training to the case management team on writing deviations and the development of remediation and CAPA actions.
 
qualifications:
  • BS/BA degree in a health related or life science related field and 3 years of drug safety experience
  • Minimum of 5 years of clinical quality compliance experience.
 
skills: CAPA, Argus, Drug Safety
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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