Patient Safety Specialist

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

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com.

We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Job Description

Patient Safety Specialist

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 strong knowledge of patient safety processes and the ability to manage multiple operational activities while maintaining accuracy, quality, and regulatory compliance.

Key Responsibilities

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

Your impact: Must have:

Education:

• Bachelor’s/PG degree in Life Sciences or Pharmacy or other relevant fields
• Strong understanding of medical terminology, healthcare documentation practices, and scientific concepts relevant to patient safety and drug safety monitoring

Experience Requirement:

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

Working Model:

• 8AM EDT to 5PM EDT, Remote Working
• Role-specific onboarding, SOP familiarization, training, and process enablement will be led by the client

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Qualifications

(Lifescience BSC/ MS/ MSC) + MBA

Additional Information

Compensation & Benefits Transparency Statement

Base Salary Range: $60k-$70k

The compensation range displayed reflects the full span of pay across all of our U.S. geographic pay areas and experience levels. Your actual base salary offer will be determined based on multiple factors, including:

• Geographic Pay Area (US 1 through US 5, reflecting cost‑of‑labor differences)
• Experience & Qualifications relevant to the role
• Internal Equity alignment with employees in similar roles and levels

What This Means for You

• The minimum of the posted range represents the starting point for candidates in the lowest cost‑of‑labor pay areas (US 5).
• The maximum of the posted range represents the upper threshold for candidates in the highest cost‑of‑labor pay areas (US 1 / US 2).
• Candidates are aligned to pay areas based on their primary work location.

For Current Employees

Posted salary ranges reflect the full compensation band across all U.S. pay areas and experience levels. Your individual compensation is based on your specific pay area, hire date, performance trajectory, and internal equity. Differences between your current salary and the posted range are not indicative of a pay discrepancy. Please contact HR with any questions.

Benefits Overview

This role is eligible for a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; a 401(k)-retirement plan; seven (7) sick leave days, vacation paid time off, and paid holidays; all in accordance with Company plans. Specific benefits are governed by applicable plan documents.

Indegene is committed to pay equity and transparency. We regularly benchmark our compensation against market data to ensure competitive and fair pay practices across all locations.