Sr. Safety Associate, Case Processing Oversight

Job Description

As the Sr. Safety Associate, Case Processing Oversight, you will be accountable for the operational management and the oversight of case processing activities performed internally, and externally, by vendors (CROs), in both the Post-Marketing and Clinical Trial settings. You will also be accountable to ensure all Adverse Event (AE) case processing is conducted in compliance with regulatory requirements and corporate and departmental procedures. You will support objectives and goals laid out by Global Case Management Leadership.

This will be a Hybrid role with onsite expectations of 2-3 days/week.

As the Sr. Safety Associate, Case Processing Oversight, you will:

• Ensure all AE case processing, in both the Post-Marketing and Clinical Trial settings, is conducted in compliance with regulatory requirements, corporate and departmental procedure and data handling conventions by maintaining and executing oversight plans for vendors (CROs) with case processing responsibilities.
• Monitor the compliance and the health of the case processing workflow continuously through use of various monitoring reports and investigation of late cases with a focus on:
  • Timely completion of outsourced case processing activities
  • Early identification of potential late or late dated cases and rapid communication to prevent or resolve late regulatory submissions
  • Investigation and root cause analysis of late cases submitted to a Health Authoritty.
• Monitor the quality of outsourced case processing activities using multiple tools with a focus on:
  • Continuous evaluation of the quality of outsourced case processing activities
  • Continuous process improvements
  • Identification of risks that could impact regulatory compliance
  • Identification of gaps in procedures
  • Identification of trends; conduct impact analysis
• Provides day to day vendor or partner support including:
  • Provide case processing SME support on day-to-day questions or during operational meetings
  • Collaborates with R&D IT to facilitate resolution of technology issues
  • Collaborates with GCM Technology and Data Insights Team (TADI) to maintain and develop case processing workflow and quality reports, as necessary
  • Support onboarding and ongoing maintenance of partner and vendor status to perform work including, but not limited to access requests, training, and technology set up.
• Support Global Case Management Departmental Goals and Projects:
  • Conduct User Acceptance (UAT) testing for GxP Systems
  • Vendor Invoice reconciliation
  • Participate in testing and conference room pilots for Global Safety Database (GSD) upgrade project
  • Work with the Case Processing Oversight Senior Manager & Associate Director to review governing documents, such as SOPs, Safety Management Plans, and Safety Data Exchange Agreements, as necessary

You are a Safety Associate who has excellent written and verbal communication skills. Your excellent organizational skills, ability to embrace change, and multi-task in an extremely fast-paced environment enables you to handle multiple priorities. You work effectively in a collaborative team environment and communicate effectively in a matrix environment. You think creatively in problem solving.

Qualifications

• Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences
• 3+ years in Drug Safety Department/ Pharmacovigilance in pharmaceutical industry setting
• Must have direct experience with end-to-end Case Processing of both Clinical Trial and Post-marketing ICSRs
• Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP
• Experience interacting with third parties (e.g., contract service providers) preferred
• Ability for individual decision-making required
• Knowledge of common safety database systems

Additional Information

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