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Sr. Triage Associate

Townsend & Associates • Pennington, NJ

Posted 17 days ago

Job Snapshot

Contractor
Travel - None
Experience - 5 to 10 years
Degree - 4 Year Degree
Competitive salary based on experience
Pharmaceutical, Healthcare - Health Services, Other Great Industries
Science, Pharmaceutical, Other
Relocation - No
75

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Job Description

Sr. Triage Associate
 

Description: Triage Associate and Senior Case Processor work directly with Sr. Triage Associate to get core daily work responsibilities completed. Sr. Triage Associate directs the team to prioritize cases and special projects and delegates when needed.

 

Responsibilities:

  • Accountable for incoming reports and information contained therein to determine the seriousness of the report, determine contractual responsibilities to assign a regulatory due date.
  • Accountable for identification of all related clinical study cases for Semi-annual report of Suspected Unexpected Serious Adverse Reaction (SUSAR).
  • Accountable for identification of potential signal detection cases and communicates this to the Medical Review Safety Physician (MRSP).
  • Organizes work load to prioritize the most urgent deliverables (i.e. reports) ultimately to execute accurate reportable timelines.
  • Utilizes knowledge of specific work practices, Safety Data Exchange Agreement (SDEA), Standard Operating Procedures (SOP), and regulations to process cases in a timely manner and lead the team to execute the process appropriately.
  • Seeks to understand and adhere to SDEA in processing cases involving products under co-marketing arrangements to handle all cases in a timely manner.
  • Serves as a resource to identify company products and designated co-marketers.
  • Incorporates medical and fundamental complex understanding of the human anatomy and its functions to process adverse event reports in an accurate and consistent manner.
  • Oversees that all follow up cases go into the appropriate case based on ICSR and liaises with MRSP if needed.
  • Develop and execute training for alignment in processing.
  • Accountable for multiple tasks, prioritizes tasks according to designated criteria and remains flexible as processes and priorities change.
  • Exercises a high degree of adaptability in dealing with an ambiguous and complex work environment, which includes demands not only from respective teams, but also from regulatory agencies, co-marketing partners and the GPV&E Medical staff.
  • Serves as a trainer, mentor, and guide for colleagues within GPV&E through providing perspective on the broad organizational impact on their daily work.
  • Coordinates the daily responsibilities and workload of the team by deploying resources and delegating appropriately and equitably to meet short term and long-term goals defined for adverse event processing.

Sr. Triage Associate 

Job Requirements

Sr. Triage Associate


W2 ONLY!!!


Qualifications:

  • Degree/Certification/Licensure Bachelors degree, Master degree Preferred, scientific/medical background (B.S./B.A, M.S.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy.
  • Minimum of 8 years pharmaceutical experience with a strong preference of 5 or more years in pharmacovigilance, drug development, clinical development, quality and/or regulatory. 
  • Mastery of health / life sciences gained through either formal education or on job experiences.
  • Mastery of AE processing both internally and externally, as well as the ability to understand the future impact.
  • Mastery of the intricacies of AWARE (the drug safety database).
  • Knowledge of drug development and commercialization process and the impact of AE Processing on that process. 
  • Knowledge of general safety reporting requirements, regulations, guidelines and procedures.
  • Experience working with a wide range of technically and culturally diverse people and influencing them to accomplish a common goal.
  • Experience utilizing problem solving techniques to ensure that AE reports are available for processing at the earliest possible time.
  • Experience supervising a team.
  • Experience communicating to a diverse audience, at multiple levels through various formats (i.e. presentations, meetings, proposals, face-to-face meeting).
  • Firsthand experience working directly with customers, technical experts and professional staff. 
  • Software that must be used independently and without assistance (e.g., Microsoft Suite).

Sr. Triage Associate

Job ID: 17-01402
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