Executive / Sr. Executive - Drug Safety Specialist

Why This Role Matters

Drug Safety Specialists play a crucial role in ensuring accurate reconciliation, regulatory compliance, and effective exchange of global safety information. Strong reconciliation and compliance monitoring processes protect patient safety and maintain regulatory trust.
At Fidelity Health Services, this role supports global pharmacovigilance operations by managing safety reconciliation activities, reference safety information updates, and regulatory database reviews.

Job Description

Fidelity Health Services is hiring an Executive / Senior Executive – Drug Safety Specialist for its Navi Mumbai location. The role focuses on safety reconciliation, compliance monitoring, global safety information exchange, and regulatory data review.
The selected candidate will coordinate with internal PV teams and global stakeholders to ensure accurate reconciliation of safety data and timely documentation updates.

Key Features of the Role

• Exposure to global pharmacovigilance operations
• Hands-on experience in safety reconciliation and compliance monitoring
• Interaction with regulatory safety databases
• Involvement in global product lifecycle safety management
• Opportunity to grow within drug safety operations

Responsibilities

• Manage safety reconciliation and compliance monitoring activities for clients
• Perform reconciliation of Reference Safety Information (RSI) for client products
• Conduct data mining and review of FDA’s Adverse Event Reporting System (FAERS) and other regulatory databases
• Edit, review, and reconcile Consolidated Global Product Lists
• Manage global exchange of safety information for product approvals, launches, cancellations, and RSI updates
• Maintain and update documentation related to safety reconciliation
• Coordinate with cross-functional teams for issue resolution
• Ensure regulatory compliance and audit readiness

Required Qualifications

• 5–8 years of experience in the Pharmacovigilance domain
• Strong experience in safety reconciliation and compliance monitoring
• Proficiency in MS Excel
• Experience in mailbox management and safety communication tracking

Educational Requirements

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

Experience and Skills

• Strong understanding of pharmacovigilance processes
• Experience with global safety information exchange workflows
• Knowledge of FAERS and regulatory safety databases
• Analytical and detail-oriented approach
• Good documentation and coordination skills
• Ability to manage multiple client deliverables and timelines

Salary Insights

• Competitive compensation based on experience
• Exposure to global drug safety projects
• Career progression opportunities in reconciliation and compliance

Company Overview

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

FAQs

Q: Is prior reconciliation experience mandatory?
Yes, hands-on experience in safety reconciliation is required.

Q: Does the role involve regulatory database review?
Yes, including FAERS and other global safety databases.

Q: Is this a client-facing role?
The role involves coordination with clients and internal PV teams.

Application Tips

• Highlight reconciliation experience clearly
• Mention exposure to FAERS or regulatory databases
• Showcase Excel proficiency (pivot tables, tracking sheets)
• Include examples of compliance monitoring or audit support experience