Medical Writer - PSMF

Roles & 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 requirements
• Ensure accuracy, completeness, and compliance of all PSMF sections with SOPs, WIs, and regulatory updates
• Manage PSMF document control including versioning, tracking, and archiving
• Develop and maintain Pharmacovigilance System Summaries
• Coordinate with internal stakeholders (PV, Regulatory, Business teams) to collect and validate inputs
• Liaise with external partners and affiliates to finalize PSMFs
• Support development, review, and updates 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:
• Proven experience in Medical Writing with focus on PSMF and pharmacovigilance documentation
• Strong understanding of global PV regulations (EU GVP Module II preferred)

Skills:
• Expertise in PSMF preparation and PV system documentation
• Experience with SOP writing and document management systems
• Strong written communication and stakeholder coordination skills
• High attention to detail and ability to manage regulatory timelines

About the Organization:
Alkem Laboratories Ltd. is one of India’s leading multinational pharmaceutical companies with a strong global presence across 50+ countries, committed to strengthening pharmacovigilance, regulatory compliance, and patient safety worldwide.