Job Title: Safety Documentation Specialist
Location: Mumbai, India
Department: Research & Development / Pharmacovigilance
Job Type: Full-Time
Experience Required: Minimum 3 Years in Pharmacovigilance Documentation or Safety Reporting
Role Overview
The Safety Documentation Specialist is responsible for managing, formatting, archiving, and distributing pharmacovigilance and medical safety documentation in compliance with global regulatory requirements. This role supports the periodic reporting and medical writing teams by ensuring safety documents such as periodic safety reports, signal evaluation reports, and health hazard assessments are processed accurately and delivered to relevant stakeholders within required timelines. The position also plays an important role in maintaining document management systems and supporting regulatory inspections and audits.
Key Responsibilities
Safety Document Management and Distribution
Process, format, distribute, and archive periodic safety reports, Risk Management Plans, and other medical safety documents according to internal procedures and regulatory standards.
Ensure all safety documentation is formatted according to eCTD requirements before submission or distribution.
Maintain accurate distribution of medical safety documents to internal teams, affiliates, and license partners.
Document Management System Administration
Serve as the GPV Business Administrator for the DARIUS Document Management System.
Manage and monitor pharmacovigilance-specific documents stored within DARIUS and ensure proper archival and version control.
Maintain electronic document repositories including common drives and internal document archives.
Pharmacovigilance Documentation Oversight
Support the maintenance and management of safety documents such as Health Hazard Assessments, signal evaluation reports, and other pharmacovigilance documentation.
Ensure document accuracy, completeness, and compliance with regulatory standards.
Audit and Inspection Support
Participate as a back-office team member during pharmacovigilance inspections and regulatory audits.
Ensure documentation systems are organized and audit-ready to support regulatory review.
PSMF Coordination Support
Act as Deputy Pharmacovigilance System Master File (PSMF) Coordinator.
Support the maintenance and updating of the Pharmacovigilance System Master File.
Provide PSMF documentation and relevant information upon internal or regulatory request.
Educational Qualifications
Diploma or Bachelor’s degree in Industrial Business Management, Documentation Management, Life Sciences, or a related field.
Experience Requirements
Minimum 3 years of industry experience in pharmacovigilance documentation, regulatory documentation management, or medical safety documentation.
Hands-on experience with document management systems and regulatory safety documentation processes.
Required Skills and Competencies
Strong knowledge of pharmacovigilance terminology and safety reporting requirements.
Experience with electronic document management systems and archives.
Proficiency in Microsoft Office applications including Excel, Word, PowerPoint, and Outlook.
Familiarity with SharePoint, e-room technology, and HTML-based documentation systems.
Good understanding of eCTD formatting and regulatory document submission requirements.
Excellent written and verbal communication skills in English.
Strong organizational, multitasking, and documentation management abilities.
High attention to detail and accuracy in document processing.
Work Location
Mumbai, India.
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