Medical Writer - PSMF

Role & Responsibilities
• Prepare, maintain, and track PSMF submission schedules to meet regulatory timelines
• Develop and update regional Pharmacovigilance System Master Files (PSMFs) as per global and local PV regulations
• Ensure accuracy, completeness, and compliance of all PSMF sections with SOPs, WIs, and regulatory updates
• Manage PSMF document control including versioning, archiving, and change tracking
• Develop and maintain Pharmacovigilance System Summaries
• Coordinate with internal stakeholders across PV, Regulatory Affairs, and Business teams for data collection and validation
• Liaise with affiliates and external partners to finalize PSMF documentation
• Support development, review, and maintenance of SOPs related to PSMF activities
• Assist during regulatory inspections, audits, and Health Authority queries related to PSMF

Qualification
• Degree in Pharmacy, Life Sciences, Medicine, or related discipline

Experience
• 2+ years of experience in Medical Writing with focus on PSMF and PV documentation

Skills
• Strong understanding of global pharmacovigilance regulations
• Hands-on experience with EU GVP Module II (preferred)
• Experience in SOP writing and document management systems
• Excellent written communication and cross-functional coordination skills
• High attention to detail with strong regulatory compliance mindset

About the Company
• Alkem Laboratories is one of India’s leading multinational pharmaceutical companies