Senior Safety Specialist – Clinical Case Processing
Location: Remote (India-based)
Employment Type: Full-Time
Experience: 8–10 Years
Qualification: B.Pharm / PharmD / BAMS / BHMS
About the Role
We are seeking an experienced Senior Safety Specialist with strong expertise in clinical trial case processing, documentation, and reconciliation. The role is responsible for managing SAE reconciliations, supporting investigative queries, ensuring database integrity, and coordinating with cross-functional teams to maintain high-quality safety processes.
This position offers a fully remote work arrangement while providing an opportunity to engage with global clinical, data management, and pharmacovigilance teams.
Key Responsibilities
SAE Reconciliation & Case Oversight
Perform SAE reconciliations using the Elluminate tool.
Assist the reconciliation team in resolving queries and escalate critical issues in IDRP meetings with CP leads, Clinical, and Data Management teams.
Review DMPs/SMPs to ensure accuracy and compliance.
Create test cases and perform UAT testing for new studies transitioning to Elluminate.
Identify eligible studies from GSL for IRE reconciliation and assign tasks to colleagues while maintaining trackers.
Track upcoming DBLs, coordinate with reconciliation, DM, and clinical teams, and act as POC for completion sign-off (typically 4–6 PM EST).
Serve as back-up for IRE reconciliation activities in the second half of the EST workday.
Investigations & Audits
Investigate cases flagged during audits, inspections, deviations, or clean-up activities.
Perform deep-dive reviews within Argus using standard case processing conventions.
Provide oversight of Targeted Follow-Up Questionnaires and Pregnancy Forms, ensuring correct assignment to cases on a quarterly basis.
Global Intake Tool (GIT) Support
Maintain working knowledge of GIT and GIT DEC, ensuring database functionality and connectivity with IRMS/AVISSO.
Provide confirmations and support to Local Safety Managers regarding database issues.
Perform testing and validations for global safety database operations.
Required Skills & Qualifications
Bachelor’s degree in Pharmacy (B.Pharm/PharmD) or alternative medicine (BAMS/BHMS).
8–10 years of clinical trial case processing experience, with a strong understanding of SAE reconciliation, documentation, and reporting.
Hands-on experience with Elluminate, Argus, and GIT systems.
Ability to coordinate and communicate effectively with cross-functional teams across clinical, data management, and safety operations.
Strong problem-solving skills and attention to detail.
Experience supporting audits, inspections, and deviation investigations.
Ability to manage time-sensitive deliverables across EST work hours and remote settings.
Why Join
Lead critical pharmacovigilance operations and clinical trial safety activities.
Collaborate with global teams and enhance your expertise in safety case processing.
Opportunity to work remotely with structured processes and mentorship opportunities.
Drive quality, compliance, and operational excellence in a dynamic pharmaceutical environment.
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