Executive Safety Writer / Senior Executive

Why This Role Matters

Safety Writers are essential to maintaining the integrity, accuracy, and regulatory compliance of aggregate safety reports. Monitoring documentation flow, tracking submissions, and ensuring timely closure of action items directly impact regulatory trust and patient safety.
At Fidelity Health Services, this role supports structured aggregate reporting processes and compliance monitoring for global pharmacovigilance operations.

Job Description

Fidelity Health Services is hiring an Executive Safety Writer / Senior Executive for its Navi Mumbai location. The role focuses on supporting aggregate report management, document tracking, compliance monitoring, and assisting in analysis of nonconformance-related action items.
The selected candidate will work closely with medical writers, aggregate reporting teams, and quality stakeholders to ensure documentation accuracy and timely workflow management.

Key Features of the Role

• Exposure to global aggregate reporting workflows
• Involvement in report tracking and compliance monitoring
• Coordination with medical writing and PV teams
• Opportunity to strengthen quality oversight skills
• Career growth within pharmacovigilance operations

Responsibilities

• Verify arrival of source documents and final signed aggregate reports
• Monitor and update online aggregate report trackers
• Ensure documentation completeness and version control
• Track submission timelines and report status updates
• Assist in analysis and follow-up of nonconformance action items
• Coordinate with internal stakeholders for document reconciliation
• Maintain compliance records and audit readiness documentation
• Support safety writing and reporting teams as required
• Identify process gaps and escalate issues appropriately

Required Qualifications

• 2–4 years of experience in safety writing and aggregate reporting
• Familiarity with aggregate report workflows (PSUR, PBRER, PADER, etc.)
• Experience in documentation tracking and compliance monitoring

Educational Requirements

• B.Pharm
• M.Pharm
• BHMS
• BAMS

Experience and Skills

• Strong understanding of aggregate reporting processes
• Experience in documentation control and tracker management
• Basic knowledge of pharmacovigilance regulations
• Good analytical and coordination skills
• Proficiency in MS Office (especially Excel)
• Attention to detail and compliance-focused approach
• Ability to manage timelines and multiple tasks

Salary Insights

• Competitive compensation aligned with experience
• Exposure to global PV and aggregate reporting operations
• Career advancement opportunities in safety writing and compliance

Company Overview

Fidelity Health Services provides end-to-end pharmacovigilance and regulatory services to global pharmaceutical clients. The organization specializes in aggregate reporting, safety reconciliation, compliance monitoring, and structured PV documentation support.

FAQs

Q: Is hands-on aggregate report drafting required?
Experience in safety writing and aggregate reporting processes is required.

Q: Does the role involve compliance monitoring?
Yes, tracking documentation and nonconformance action items is a key responsibility.

Q: Is this a client-facing role?
Primarily internal coordination, but interaction with cross-functional teams is involved.

Application Tips

• Mention types of aggregate reports handled
• Highlight experience with report trackers and documentation systems
• Include exposure to quality audits or nonconformance management
• Emphasize organizational and compliance skills