Executive / Senior Executive – Drug Safety Specialist
Location: Navi Mumbai, India
Job Overview
The Executive / Senior Executive – Drug Safety Specialist is responsible for pharmacovigilance reconciliation and compliance monitoring activities. The role ensures consistency of global safety information, supports regulatory compliance, and manages safety data exchange processes across products and markets.
Qualifications
B.Pharm / M.Pharm
Experience Requirements
5–8 years of experience in Pharmacovigilance (PV) domain
Strong proficiency in:
MS Excel
Mailbox / email-based workflow management
Key Responsibilities
A. Safety Reconciliation Activities
Manage safety reconciliation processes for client products
Reconcile Reference Safety Information (RSI) across global product portfolios
Ensure alignment of safety data across different regulatory sources
B. Regulatory Database Review & Data Mining
Perform data mining and review of:
FDA Adverse Event Reporting System (FAERS)
Other global regulatory safety databases
Identify relevant safety signals and discrepancies
C. Global Product Safety Management
Edit, review, and reconcile Global Product Lists
Maintain consistency of safety information across product lifecycle stages
Support updates related to product approvals, launches, cancellations, and RSI revisions
D. Safety Information Exchange
Manage global exchange of safety information between partners and stakeholders
Ensure timely and accurate communication of safety updates
Support pharmacovigilance compliance during regulatory submissions and lifecycle changes
E. Compliance Monitoring & Documentation
Monitor compliance with pharmacovigilance requirements
Maintain and update documentation related to safety reconciliation activities
Ensure audit readiness of reconciliation records and workflows
Core Skills Required
Pharmacovigilance reconciliation and compliance monitoring
Knowledge of FAERS and global safety databases
Reference Safety Information (RSI) management
Data mining and safety data review
Strong MS Excel skills (data handling, tracking, analysis)
Email/workflow management systems
Soft Skills
Strong attention to detail
Analytical and data interpretation skills
Ability to manage multiple global datasets and workflows
Strong communication and coordination abilities
Process-oriented mindset
Work Environment
Global pharmacovigilance operations environment
Data-heavy reconciliation and compliance role
Cross-functional coordination with global safety teams and clients
Highly regulated, audit-driven workflow setting
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Norway | NOrway |Romania :
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Galway |County Dublin :
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Canada |Quebec :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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