Are you a passionate M.Pharm professional looking to advance your career in Pharmacovigilance?
Macleods Pharmaceutical Ltd., one of India’s leading pharma companies, is hiring for a Safety Variations Specialist role at its R&D center in Andheri, Mumbai.
This position offers a dynamic opportunity to work on European and UK Safety Variation processes, SmPC/PIL updates, and regulatory safety data management. If you have 1–2 years of experience in Pharmacovigilance and are ready to grow with a reputed organization, this could be the ideal role for you!
🧪 Job Title: Safety Variations – Pharmacovigilance
Department: R&D – Pharmacovigilance
Location: Andheri, Mumbai
Work Type: On-site (Work from Office)
Experience Required: 1–2 years
Qualification: M.Pharm (Pharmacology / Pharmaceutics)
📋 Key Responsibilities
As part of the Pharmacovigilance Safety Variations team, your key responsibilities include:
- Updating SmPC (Summary of Product Characteristics) and PIL (Patient Information Leaflet) for Europe and UK markets based on PRAC, CMDh, CHMP, and Signal requirements.
- Monitoring and reviewing regulatory updates from EMA, MHRA, EC, and HMA websites.
- Collaborating with Regulatory Affairs (RA) for innovator references, text harmonization, and compliance queries.
- Conducting safety-related change assessments and ensuring timely RSI (Reference Safety Information) updates.
- Comparing and reviewing SmPC/PIL documents regularly to identify changes as per SOPs.
🎓 Educational Qualifications
- M.Pharm in Pharmacology or Pharmaceutics
- Experience: 1–2 years in Pharmacovigilance (Freshers not eligible)
💼 Why Join Macleods Pharmaceutical Ltd.?
- Work with one of India’s most respected pharmaceutical organizations.
- Exposure to global regulatory environments (Europe and UK).
- Professional growth in safety and regulatory documentation.
- Collaborative, science-driven work culture.
📧 How to Apply
Interested candidates can send their updated resume to:
📩 adityab@macleodspharma.com
