Job Title: Senior Safety Specialist – Pharmacovigilance
Location: Remote
Employment Type: Full-Time
Experience Required: 8–10 years
Qualification: B.Pharm / PharmD / BAMS / BHMS
Role Overview:
We are seeking a highly experienced Senior Safety Specialist with a strong background in clinical trial case processing, documentation, and reconciliation. The ideal candidate will manage safety case reconciliations, support investigations, and act as a key point of contact for internal stakeholders across pharmacovigilance, clinical, and data management teams.
Key Responsibilities:
1. SAE Reconciliation:
Perform SAE reconciliations using Elluminate and assist reconciliation teams with queries.
Escalate unresolved issues during study meetings with CP leads, Clinical, and Data Management teams.
Coordinate with CP leads and participate in IDRP meetings (1–4 PM EST) to highlight discrepancies.
Review DMPs / SMPs, create test cases, and conduct UAT testing for new studies transitioning to Elluminate.
Identify eligible studies from GSL for IRE reconciliation and assign to colleagues, maintaining accurate trackers.
Track upcoming DBLs and coordinate with reconciliation, DM, and clinical teams to resolve discrepancies; act as POC for completion form sign-off (typically 4–6 PM EST).
Serve as backup for all IRE reconciliation activities during the second half of EST day.
2. Investigations & Case Oversight:
Investigate cases arising from audits, inspections, deviations, clean-up activities, and queries from Local Safety Managers.
Conduct deep-dive analysis in Argus, ensuring adherence to case processing conventions.
Oversee Targeted Follow-Up Questionnaires and Pregnancy forms, ensuring proper assignment to cases and quarterly review.
3. Global Intake Tool (GIT) Responsibilities:
Utilize GIT and GIT DEC to confirm database functionality.
Test connectivity with IRMS / AVISSO and respond to Local Safety Manager queries regarding database performance.
Qualifications & Skills:
Pharmacy Graduate (B.Pharm / PharmD) or equivalent (BAMS/BHMS considered).
8–10 years of pharmacovigilance experience with strong clinical trial case processing expertise.
Hands-on experience with Elluminate, Argus, GIT, DBL, IRE reconciliation, and related PV tools.
Strong analytical, problem-solving, and documentation skills.
Excellent communication and stakeholder management skills.
Ability to work independently in a remote environment and across multiple time zones (EST focus).
Why Join:
Fully remote role with flexible work structure.
Opportunity to lead critical pharmacovigilance reconciliation and investigation activities.
Collaborate with global teams across Clinical, Data Management, and Safety.
Work in a dynamic, high-impact pharmacovigilance environment with opportunities for professional growth.
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