Global Safety Operations Contract Specialists (Contract/Remote)

Oversee and ensure the data quality and compliance of adverse event collection and reporting. This role involves but is not limited to medically focused review of expedited and high interest safety reports, preparation of regulatory submissions, monitoring corrections, quality control (QC) of adverse event reports, serious adverse event (SAE) reconciliation, and managing license partner data exchange compliance metrics. The ideal candidate will have extensive experience with the Argus safety database and pharmacovigilance case processing workflows.

Key Accountabilities:

• Clinical Trial Adverse Event Reporting:
  • Oversee and manage the reporting of adverse events in clinical trials.
  • Ensure timely and accurate reporting in compliance with regulatory requirements.
• Medical Review of Expedited Safety Reports:
  • Conduct thorough medical reviews of expedited safety reports and high interest events including causality assessment
  • Evaluate the clinical significance of adverse events and ensure appropriate follow-up actions/queries are actioned.
• Preparation of Regulatory Submissions:
  • Prepare and review regulatory submissions related to safety reporting.
  • Ensure all submissions are accurate, compliant, and submitted within required timelines.
  • Construct analysis of similar events (AOSE) summaries to fulfill FDA expedited submission regulations.
• Corrections Monitoring:
  • Monitor and track corrections of safety reports to ensure data integrity.
  • Implement process improvements based on trending data to reduce errors and compliance risk.
• Quality Control (QC) of Adverse Event Reports:
  • Perform quality control checks on individual case safety reports to ensure completeness and accuracy.
  • Identify and address any discrepancies or issues in the reports.
  • Conduct case processing vendor feedback based on QC findings and participate in vendor training support meetings.
• Reconciliation:
  • Oversight of clinical trial reconciliation to ensure all events are captured accurately in the COMPANY Safety database.
  • Collaborate with clinical teams to resolve any discrepancies.
• License Partner Compliance Metrics:
  • Monitor and manage compliance metrics for license partners.
  • Ensure all partners adhere to safety reporting requirements and standards.
• General Safety Operations oversight:
  • Assist in general oversight and address inquires in central mailbox related to ICSRs from clinical trial, post-marketing solicited and spontaneous sources.
  • Assist in deviation investigations, root cause analysis and corrective actions.
  • Support backroom activities during audit and inspections.

Education Level:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field; strong preference for candidates with nursing degree and associated clinical judgement.

Required Experience:

• Minimum of 5 years of experience in pharmacovigilance, drug safety. Pharmaceutical experience a plus.
• Extensive experience with the Argus safety database and case processing workflow.
• Strong knowledge of global regulatory requirements for safety reporting.
• Proven experience in clinical trial adverse event reporting, quality control and assessment.
• Experience in preparing regulatory submissions and ensuring compliance.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a multidisciplinary team.
• Strong organizational and time management skills to manage multiple tasks and projects simultaneously.