Patient Safety Specialist

INDEGENE LIMITED • New Jersey, NJ

5d • $60,000 - $70,000 • Remote

About The Position

The Patient Safety Specialist supports pharmacovigilance operations through PV package management, safety documentation, quality control, mailbox management, reconciliation, compliance tracking, and inspection readiness. The role requires knowledge of patient safety processes and the ability to manage multiple operational activities while maintaining accuracy, quality, and regulatory compliance. The position is remote, with working hours of 8:00 AM to 5:00 PM EDT. Role-specific onboarding, SOP familiarization, training, and process enablement will be led by the client.

Requirements

• Strong understanding of PV processes in the Patient Safety function, adverse event management, safety documentation, and reconciliation activities.
• Expertise in maintaining inspection-ready documentation, version control, and compliance with GVP/GCP requirements.
• Proven ability to manage reconciliations, compliance trackers, operational logs, and multiple concurrent deliverables.
• Proficiency in safety databases, PV tracking platforms, and document management systems supporting PV operations.
• Bachelor’s or postgraduate degree in Life Sciences, Pharmacy, or another relevant field.
• Strong understanding of medical terminology, healthcare documentation practices, and scientific concepts relevant to patient safety and drug safety monitoring.
• 3–5 years of experience in Pharmacovigilance Operations in PDCSs.

Nice To Haves

• Exposure to patient support programs, specialty pharmacy programs, or post-marketing safety operations.

Responsibilities

• Manage end-to-end PV package preparation, documentation control, and maintenance of safety-related records in compliance with program and regulatory requirements.
• Perform quality reviews of safety cases and documentation to ensure accuracy, consistency, and regulatory compliance.
• Oversee PV mailbox operations, including query triage, case routing, follow-up tracking, and stakeholder communication.
• Maintain educational program documentation, physician attestations, and audit-ready filing systems.
• Manage reconciliation activities and compliance trackers across multiple patient support and specialty programs.
• Ensure inspection readiness through documentation governance, compliance monitoring, and audit support activities.

Benefits

• Medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) retirement plan.
• Seven sick leave days.
• Vacation paid time off.
• Paid holidays.

What This Job Offers

• Job Type: Full-time