Safety Documentation Specialist Pharmacovigilance

Roles & Responsibilities
• Distribute medical safety documents to internal stakeholders, affiliates, and license partners
• Process, format, and archive periodic safety reports and Risk Management Plans (RMP)
• Perform eCTD formatting and document publishing as per global pharmacovigilance regulations
• Act as GPV Business Administrator for the DARIUS Document Management System
• Manage GPV-specific documents and oversee archiving activities in DARIUS
• Maintain electronic archives, SharePoint drives, and document repositories
• Support pharmacovigilance inspections and audits through back-office documentation support
• Serve as Deputy PSMF Coordinator and assist in maintaining the Pharmacovigilance System Master File (PSMF)
• Provide PSMF documentation to regulatory authorities upon request
• Ensure compliance with global safety reporting requirements and document lifecycle management standards

Qualification
• B.Pharm, M.Pharm, Pharm.D, MSc, BSc (Life Sciences) or equivalent qualification
• Industrial Business Management Assistant / Documentation Specialist qualification preferred

Experience
• Minimum 3 years of experience in pharmacovigilance documentation or safety reporting
• Strong experience in eCTD formatting and publishing
• Experience handling PSUR, DSUR, PBRER, and RMP documentation
• Experience with DARIUS Document Management System
• Experience in PSMF maintenance and regulatory documentation

Vacancies
• 1 Vacancy

Skills
• Advanced knowledge of global pharmacovigilance terminology and regulations
• Strong expertise in document management systems
• Proficiency in Microsoft Excel, Word, PowerPoint, and Outlook
• Knowledge of SharePoint and e-room technology
• Basic HTML knowledge preferred
• Strong multitasking and organizational skills
• Detail-oriented approach with audit readiness exposure
• Excellent written and verbal English communication skills

About the Company
Abbott is a leading global healthcare and research-driven organization focused on innovation across pharmaceuticals, diagnostics, medical devices, and nutrition. With a strong presence in Research & Development, Abbott provides opportunities to work on global pharmacovigilance systems, regulatory compliance frameworks, and safety documentation processes aligned with international standards.