Patient Safety Specialist (Fully Remote)

Indegene; United States; Remote; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, and Vision coverage

Life and disability insurance

401(k) retirement plan

Paid holidays and vacation PTO

Job summary

Indegene is a technology-led healthcare solutions provider delivering PV capabilities and safety documentation. The role focuses on managing pharmacovigilance packages, quality control, and inspection readiness to support patient safety programs.

You will oversee PV mailbox operations, coordinate with stakeholders, and maintain reconciliation and compliance trackers to ensure regulatory readiness and data integrity across safety programs.

Qualifications

• Strong understanding of pharmacovigilance processes and adverse event management.
• Expertise in GVP/GCP compliance and inspection-ready documentation.
• Proficiency with safety databases and document management systems.

Responsibilities

• Manage end-to-end PV package preparation and quality control.
• Oversee PV mailbox operations and stakeholder communication.
• Handle reconciliation activities and compliance trackers.

Skills

PV processes & AE management

GVP/GCP compliance

Safety databases

Document management systems

Tools

Safety databases

Job description

• You will support pharmacovigilance operations, managing PV packages and safety documentation.
• You ensure compliance tracking and inspection readiness for patient safety programs.

Key Responsibilities:

• Manage end-to-end PV package preparation and quality control.
• Oversee PV mailbox operations and stakeholder communication.
• Handle reconciliation activities and compliance trackers.

Required Skills:

• Strong understanding of PV processes and adverse event management.
• Expertise in GVP/GCP compliance and inspection-ready documentation.
• Proficiency in safety databases and document management systems.
• Medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) retirement plan, paid holidays, and vacation PTO.

Indegene is a technology-led healthcare solutions provider that enables healthcare organizations to be future-ready. We offer accelerated growth opportunities and a culture of entrepreneurship, innovation, collaboration, and empathy.