Safety and Risk Assessment Specialist

2 weeks ago


Arvada, Colorado, United States AA2IT Full time
Job Overview

Position Type: Part-time (20 hours/week)

Work Arrangement: Remote, Hybrid, or Onsite (flexible based on candidate's preference)

Availability: Must be available for meetings during the hours of 9 AM to 3 PM EST.

Schedule: The 20 hours can be distributed over 5 days.

Contract Duration: Potential for extension beyond 6 months.

Qualifications

Education:

  • Graduate degree in nursing, health sciences, pharmacology, epidemiology, public health, or related health fields.
  • Advanced degrees such as Pharm-D, PhD, or MD are preferred.

Experience:

  • A minimum of 3 years in clinical, pharmacological, or a related field.
  • Strong writing and communication skills are essential.
  • Experience in data analysis or interpreting adverse experience information is advantageous.
  • Direct patient interaction is not required.
  • An active license is not necessary.

Essential Skills:

  • Prior experience in Contract Research Organizations (CROs) or academia is beneficial.
  • Industry experience is preferred.
  • Ability to aggregate and review adverse event reports.
  • Review of Individual Case Safety Reports (ICSR).
  • Assessment of adverse event narratives.
  • Evaluation of social media posts related to adverse events.
  • Experience in therapeutic areas such as oncology and general medicine is a plus, but other therapeutic area experience is acceptable.

Key Responsibilities:

  • Oversee Safety & Risk Management for both Developmental and Marketed Products.
  • Conduct safety analyses for clinical and post-marketing data.
  • Collaborate closely with physicians and other teams, including Clinical & Regulatory.
  • Perform primary medical reviews of serious adverse experience reports and other relevant AE reports to monitor and describe the safety profile of assigned products.
  • Contribute to the oversight and development of pharmacovigilance and risk management plans with guidance from the CSRM team.
  • Assist the CSRM team in preparing responses to inquiries from health professionals and regulatory agencies regarding reported adverse experiences.
  • Strategize with the safety team to recommend appropriate data for responding to queries and analyze data effectively.

Technical Proficiencies:

  • Proficient in MS Office Suite, Veeva (SOPs), and RXlogix (PV signals platforms).
Company Overview

AA2IT is dedicated to your success through effective strategy, execution, and value creation. We recognize that many businesses have well-structured strategies that often remain unutilized. Our focus is on executing strategies effectively and measuring what truly matters to drive value.

As a global firm based in Texas, AA2IT specializes in Staffing and IT Solutions, delivering successful talent acquisition and technology services. We operate as a fully digital organization with a people-centric and technology-driven vision.



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