Pharmacovigilance Job for Safety Variations at Macleods Pharma
Safety Variations – Pharmacovigilance
Company: Macleods Pharmaceuticals Ltd.
Department: R&D – Pharmacovigilance
Qualification: M.Pharm in Pharmacology or Pharmaceutics
Location: Andheri, Mumbai
Experience: 1–2 Years
Work Type: On-site (Work from Office)
Application Mode: Email Application
Status: Verified Job
About the Company
Macleods Pharmaceuticals Ltd. is one of India’s leading research-driven pharmaceutical companies, known for its commitment to innovation, quality, and patient safety. With a strong presence across more than 140 countries, Macleods continues to set benchmarks in healthcare through its R&D excellence and regulatory expertise. Pharmacovigilance Job for Safety Variations at Macleods Pharma
About the Role
Macleods Pharmaceuticals is hiring qualified M.Pharm professionals for the position of Safety Variations Specialist – Pharmacovigilance at its R&D center in Andheri, Mumbai.
This role provides an excellent opportunity to work on European and UK regulatory safety variation processes, including SmPC/PIL updates, PRAC/CMDh assessments, and RSI management. Candidates with 1–2 years of pharmacovigilance experience will find this position ideal for professional advancement in regulatory safety functions. Pharmacovigilance Job for Safety Variations at Macleods Pharma
Key Responsibilities
As part of the Pharmacovigilance Safety Variations team, the selected candidate will be responsible for: Pharmacovigilance Job for Safety Variations at Macleods Pharma
- Updating SmPC (Summary of Product Characteristics) and PIL (Patient Information Leaflet) for Europe and UK markets based on PRAC, CMDh, CHMP, and Signal assessment requirements.
- Monitoring and reviewing regulatory updates from EMA, MHRA, EC, and HMA websites.
- Collaborating with the Regulatory Affairs (RA) team for innovator reference documents, text harmonization, and compliance queries.
- Conducting safety-related change assessments and ensuring timely updates of RSI (Reference Safety Information).
- Comparing, tracking, and reviewing SmPC/PIL documents to identify changes and ensure alignment with current SOPs and regulatory requirements.
Educational Qualification and Experience
- Qualification: M.Pharm in Pharmacology or Pharmaceutics
- Experience: 1–2 years of relevant experience in Pharmacovigilance (freshers are not eligible)
Why Join Macleods Pharmaceuticals?
- Opportunity to work with one of India’s most trusted and reputed pharmaceutical organizations.
- Direct exposure to European and UK regulatory frameworks for pharmacovigilance and safety documentation.
- Professional development in regulatory safety variations and scientific documentation processes.
- A collaborative and innovation-focused work environment that encourages continuous learning and growth.
- Pharmacovigilance Job for Safety Variations at Macleods Pharma
How to Apply
Interested and eligible candidates can send their updated CV to the email address below:
Email: adityab@macleodspharma.com
Please mention “Application for Safety Variations – Pharmacovigilance” in the subject line while applying. Pharmacovigilance Job for Safety Variations at Macleods Pharma
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