Senior Executive – Pharmacovigilance
Job Code: PZPV011
Location: Ahmedabad, India
Department: Pharmacovigilance (PSMFSDEAs)
Job Overview
The Senior Executive – Pharmacovigilance is responsible for preparing and authoring key regulatory pharmacovigilance documents, including aggregate safety reports, risk management plans, and signal management reports. The role involves data extraction, analysis, literature review, and ensuring timely submission of safety deliverables to health authorities.
Qualifications
B.Pharm / M.Pharm
Experience Requirements
2–4 years of experience in Pharmacovigilance
Experience in safety writing and aggregate reporting preferred
Key Responsibilities
A. Aggregate Safety Report Writing
Author and prepare regulatory aggregate reports, including:
PSUR (Periodic Safety Update Report)
PBRER (Periodic Benefit-Risk Evaluation Report)
PADER (Periodic Adverse Drug Experience Report)
DSUR (Development Safety Update Report)
Annual Safety Reports
ACO reports (as applicable)
Ensure accuracy, consistency, and regulatory compliance in all reports
Submit reports to local and global health authorities within timelines
B. Risk Management & Signal Management
Author Risk Management Plans (RMPs) as part of PV activities
Prepare Signal Management Reports
Support evaluation and documentation of safety signals
C. Data Handling & Analysis
Perform literature search and validate findings for inclusion in reports
Extract and validate data from multiple sources:
Reference Safety Information (RSI)
Sales data
Previous reports
RMP documents
Signal databases
Generate Line Listings (LL) from safety databases
D. Compliance & Tracking
Reconcile and maintain relevant PV process trackers
Ensure data integrity and consistency across reporting systems
Support audit readiness of all pharmacovigilance deliverables
E. Ad-hoc & Operational Support
Provide support for high-priority or urgent safety-related activities
Assist cross-functional teams as required
Ensure timely completion of all assigned deliverables
Core Skills Required
Pharmacovigilance aggregate report writing
Regulatory safety reporting (PSUR, PBRER, DSUR, RMP, etc.)
Signal management and safety evaluation
Literature search and scientific evaluation
Safety database handling and line listing generation
Data extraction and validation
Understanding of global PV regulatory requirements
Soft Skills
Strong scientific writing ability
Attention to detail and accuracy
Ability to manage strict regulatory timelines
Analytical thinking and data interpretation
Coordination and multitasking in a regulated environment
Work Environment
Regulatory pharmacovigilance reporting environment
High-volume document writing and data analysis role
Global compliance-driven setting with strict deadlines
Cross-functional collaboration with safety and regulatory teams
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Japan | Saitama |Tokyo :
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