Pharmacovigilance & Patient Safety Lead (Remote)

Indegene; United States; Remote; USD 60,000 - 70,000; Full time

Job summary

Indegene is seeking a Patient Safety Specialist to support pharmacovigilance operations, package management, quality control, and audit readiness. You will ensure compliance with GVP/GCP and maintain inspection-ready safety documentation across multiple programs.

You will manage PV mailbox operations, case routing, and trackers, while collaborating with cross-functional teams to sustain accurate safety records and timely safety reports. Remote-friendly role with US-based teams.

Qualifications

• 3-5 years of experience in Pharmacovigilance Operations in PDCSs.
• Exposure to patient support programs or post-marketing safety operations preferred.

Responsibilities

• PV Package Management: Manage end-to-end PV package prep and documentation control per regulations.
• Quality Control: Perform quality reviews of safety cases and documentation for accuracy and compliance.
• PV Mailbox Management: Oversee PV mailbox operations, query triage, case routing and follow-up.
• Documentation Management: Maintain education program documentation, physician attestations, and audit-ready filing.
• Reconciliation & Tracking: Manage reconciliations and compliance trackers across programs.
• Compliance & Audit Support: Support inspection readiness through governance and audit support.
• Strong understanding of PV processes, AE management, safety documentation and reconciliation.
• Maintenance of inspection-ready documentation, version control and GVP/GCP compliance.
• Proven ability to manage reconciliations, trackers, logs and multiple deliverables.
• Proficiency in safety databases and PV tracking platforms and document management systems.

Skills

Pharmacovigilance

GVP/GCP compliance

Safety documentation

QA & auditing

Education

Lifescience BSC/MS/MSC + MBA

Job description

Indegene is seeking a Patient Safety Specialist to support pharmacovigilance operations, package management, quality control, and audit readiness. You will ensure compliance with GVP/GCP and maintain inspection-ready safety documentation across multiple programs.

You will manage PV mailbox operations, case routing, and trackers, while collaborating with cross-functional teams to sustain accurate safety records and timely safety reports. Remote-friendly role with US-based teams.