Executive Safety Writer / Senior Executive (Pharmacovigilance)
Location: Navi Mumbai, India
Job Overview
The Executive Safety Writer / Sr Executive is responsible for supporting pharmacovigilance aggregate report operations by tracking document flow, maintaining reporting systems, and assisting in quality and compliance monitoring of safety deliverables.
The role focuses more on operational coordination and tracking of safety writing workflows rather than full authorship of regulatory reports.
Qualifications
B.Pharm / M.Pharm / BHMS / BAMS
Experience Requirements
2–4 years of experience in:
Safety writing
Aggregate report support activities
Exposure to pharmacovigilance documentation workflows preferred
Key Responsibilities
A. Document Tracking & Management
Monitor arrival of source documents required for aggregate safety reports
Track final signed-off versions of aggregate reports
Ensure timely availability and version control of regulatory documents
B. Aggregate Report Tracking Support
Maintain and update online aggregate report trackers
Monitor status of ongoing pharmacovigilance reporting activities
Ensure visibility of report progress across teams
C. Compliance & Quality Support
Assist in reviewing action items from non-conformance reports
Track and follow up on pending corrective actions
Support quality compliance activities related to safety writing workflows
D. Coordination & Workflow Support
Coordinate with internal PV teams for document flow management
Ensure smooth communication between stakeholders involved in report preparation and approval
Support administrative aspects of aggregate report lifecycle
Core Skills Required
Understanding of pharmacovigilance aggregate reporting workflows
Experience in safety writing support functions
Document tracking and version control
Knowledge of PV compliance processes
Familiarity with trackers and reporting tools
Soft Skills
Strong organizational skills
Attention to detail
Ability to follow structured workflows
Coordination and communication skills
Ability to manage deadlines and multiple trackers
Work Environment
Pharmacovigilance operations and reporting support environment
Highly process-driven and documentation-focused role
Coordination with global or regional PV teams
Compliance-oriented workflow execution
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