Drug Safety Specialist

Job Description

Job Title: Safety Specialist/Sr. Triage Associate

Job ID: 21435-1

Location: Pennington, New Jersey- 08534

Duration: 6+ month with potential for extension

Ideal candidate will be a Nurse with PV experience

Job 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.

Key Responsibilities and Major Duties
• 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 in order 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 in order to handle all cases in a timely manner. Serves as a resource to identify CLIENT products and designated co-marketers.
• Incorporates medical and fundamental complex understanding of the human anatomy and its functions in order 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 also 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 in order 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.

List of minimum requirements
• 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

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.

Competencies – knowledge, skills, abilities, other
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 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 (i.e. presentations, meetings, proposals, face-to-face meeting).
• 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)

Qualifications

Additional Information

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