Drug Safety Specialist

Artech Information System
, a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients and we currently have a job opening that may interest you.

Job Title: Safety Specialist/Sr. Triage Associate

Job : 21435-1

Duration: 6+ month with potential for extension

Ideal candidate: Nurse with PV experience

Description: Sr. Triage Associate / Safety Specialist

Department Title and

Description:

Case Creation / Triage

Purpose / Objective of the Job: Lead subject matter expert in prioritizing cases and entering critical data in order to meet regulatory reporting responsibilities.

• Accountable for incoming reports and information contained therein to determine the seriousness of the report, determine contractual responsibilities in order 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 in order 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 CLIENT products and designated co-marketers.
• Incorporates medical and fundamental understanding of human anatomy and its functions to process adverse event reports accurately and consistently.
• 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, including demands from teams, regulatory agencies, co-marketing partners and GPV&E Medical staff.
• Serves as a trainer, mentor, and guide for colleagues within GPV&E by 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.

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.

• Degree/Certification/Licensure: Bachelor’s degree, Master degree preferred, scientific/medical background (B.S./B.A, M.S.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy.

Experience – Responsibility and minimum number of years: 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-the-job experiences.
• Mastery of AE processing both internally and externally, and the ability to understand the future impact.
• Mastery of the intricacies of AWARE (the CLIENT drug safety database).
• Knowledge of CLIENT 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 (e.g., presentations, meetings, proposals, face-to-face meetings).
• First-hand experience working directly with customers, technical experts and professional staff.

Software that must be used independently and without assistance (e.g., Microsoft Suite)

All your information will be kept confidential according to EEO guidelines.