[Hiring] Patient Safety Specialist @INDEGENE LIMITED

Role Description

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.

• 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.

Qualifications

• 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.
• (Lifescience BSC/ MS/ MSC) + MBA.

Requirements

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

Benefits

• Comprehensive benefits package, including medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) retirement plan.
• Seven (7) sick leave days, vacation paid time off, and paid holidays.
• Specific benefits governed by applicable plan documents.