Medical Writer – PSMF Job at Alkem Laboratories, Mumbai

Alkem Laboratories Ltd., one of India’s top multinational pharmaceutical companies, is hiring a Medical Writer – PSMF for its Mumbai location. This is a full-time, on-site pharmacovigilance medical writing role, ideal for professionals experienced in PSMF preparation, PV system documentation, and regulatory compliance.

With a strong global presence across 50+ countries and leading brands such as Pan, Pan-D, Clavam, and Taxim-O, Alkem continues to strengthen its pharmacovigilance and regulatory operations.

📌 Job Highlights

• Position: Medical Writer – PSMF
• Company: Alkem Laboratories Ltd.
• Location: Mumbai, Maharashtra
• Job Type: Full-time | On-site
• Department: Pharmacovigilance / Medical Writing
• Application Mode: Easy Apply

🔍 Key Responsibilities – Medical Writer (PSMF)

• Prepare, maintain, and track PSMF submission schedules to ensure regulatory timelines.
• Develop and update regional Pharmacovigilance System Master Files (PSMFs) in line with global and local regulations.
• Ensure all PSMF sections are accurate, complete, and compliant with SOPs, WIs, and regulatory updates.
• Manage PSMF document control, including versioning and archiving.
• Develop and maintain PV System Summaries.
• Collaborate with internal stakeholders (PV, Regulatory, Business teams) to gather and validate inputs.
• Coordinate with external partners and affiliates to finalize PSMFs.
• Support development and review of SOPs related to PSMF activities.
• Assist during regulatory inspections, audits, and health authority queries related to PSMF.

🎓 Required Qualifications & Skills

• Degree in Pharmacy, Life Sciences, Medicine, or related discipline.
• Proven experience in Medical Writing – PSMF / Pharmacovigilance Documentation.
• Strong understanding of global PV regulations (EU GVP Module II preferred).
• Experience with SOP writing, document management systems, and audit support.
• Excellent written communication and cross-functional collaboration skills.
• Attention to detail and ability to manage regulatory timelines.

💼 Why Join Alkem Laboratories?

• Work with a top 5 pharmaceutical company in India.
• Exposure to global pharmacovigilance systems.
• Strong learning curve in regulatory medical writing.
• Stable organization with long-term career growth.
• Competitive compensation and professional work environment.

💰 Salary (Estimated)

💵 ₹8,00,000 – ₹14,00,000 per annum
(Salary may vary based on experience, skills, and interview performance)

📝 How to Apply

Application Link