Executive / Sr. Executive - Drug Safety Specialist

Why This Role Matters

Pharmacovigilance reconciliation and compliance monitoring are critical to maintaining global drug safety standards. Accurate reconciliation of safety data ensures consistency between regulatory submissions, reference safety information (RSI), and global product databases—ultimately safeguarding patient health and maintaining regulatory compliance.
At Fidelity Health Services, this role plays a key part in managing global safety information exchange, reconciliation activities, and compliance oversight for multiple clients.

Job Description

Fidelity Health Services is seeking experienced Pharmacovigilance professionals for its Navi Mumbai location. The position focuses on safety reconciliation, compliance monitoring, RSI management, and global exchange of safety information across product lifecycles.
The selected candidate will support client-specific safety operations, manage global product listings, and ensure regulatory alignment with international pharmacovigilance requirements.

Key Features of the Role

• Exposure to global pharmacovigilance operations
• Involvement in safety reconciliation and compliance monitoring
• Interaction with international regulatory databases (e.g., FAERS)
• Management of global safety information exchange
• Opportunity to work with multinational client portfolios

Responsibilities

• Manage safety reconciliation activities for assigned clients
• Perform reconciliation of Reference Safety Information (RSI)
• Conduct data mining and review of FDA’s FAERS and other regulatory databases
• Edit, review, and reconcile Consolidated Global Product Lists
• Manage global exchange of safety information related to product approvals, launches, cancellations, and RSI updates
• Monitor compliance metrics and reporting timelines
• Maintain and update safety reconciliation documentation
• Ensure data accuracy and regulatory compliance
• Coordinate with cross-functional PV and regulatory teams
• Support audit readiness and documentation reviews

Required Qualifications

• 5–8 years of experience in Pharmacovigilance domain
• Hands-on experience in safety reconciliation and compliance monitoring
• Experience working with global regulatory databases
• Proficiency in MS Excel and mailbox management

Educational Requirements

• Bachelor of Pharmacy
• Master of Pharmacy

Experience and Skills

• Strong understanding of global PV regulations
• Experience in RSI reconciliation and safety database review
• Knowledge of FAERS and regulatory data mining
• Good analytical and documentation skills
• Strong attention to detail and compliance mindset
• Ability to manage multiple client deliverables
• Effective communication and coordination skills

Salary Insights

• Competitive compensation based on PV experience
• Exposure to global pharmacovigilance operations
• Growth opportunities in safety compliance and regulatory functions

Company Overview

Fidelity Health Services is a pharmacovigilance and regulatory support organization providing end-to-end drug safety services to global pharmaceutical clients. The company specializes in safety operations, reconciliation management, and compliance monitoring in regulated markets.

FAQs

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

Q: Is FAERS knowledge important?
Yes, data mining and review of FAERS and regulatory databases is a key responsibility.

Q: Does the role involve global coordination?
Yes, management of global safety information exchange is part of the role.

Application Tips

• Highlight reconciliation projects handled
• Mention RSI management experience
• Include exposure to FAERS or regulatory databases
• Emphasize Excel proficiency and compliance monitoring expertise