Macleods Pharmaceutical Ltd., one of India’s leading research-driven pharmaceutical companies, is hiring an RMP Drafter for its Pharmacovigilance (PV) – R&D Department in Andheri, Mumbai.
If you have 1–2 years of experience in drug safety, PSUR/PBRER review, and RMP documentation, this is a great opportunity to advance your PV career with a globally recognized organization.
This article covers the full job description, responsibilities, eligibility, benefits, and how to apply.
🔍 Job Overview
- Role: RMP Drafter – Pharmacovigilance
- Department: PV – R&D
- Company: Macleods Pharmaceutical Ltd.
- Location: Andheri, Mumbai
- Experience Required: 1–2 years
- Qualification: M.Pharm (Pharmacology)
- Work Mode: On-site
- Vacancies: 01
- Application Email: adityab@macleodspharma.com
💼 Key Responsibilities of RMP Drafter
The selected candidate will be responsible for end-to-end safety document management, including:
1. Safety Document Review
- Quality review of PSUR, PBRER, ACO, and Risk Management Plans (RMPs)
- Regions: Europe/UK, India, ROW markets
2. Safety Report Planning
- Preparation and maintenance of PSUR/PBRER/ACO calendars
- Allocation of safety documents to the internal team
- Ensuring timely submission to Regulatory Affairs (RA)/Local Regulatory Person (LRP) or respective authority
3. Regulatory Compliance
- Drafting and updating SOPs and SGDs as per global PV guidelines
- Handling safety-related queries from regulatory agencies
- Preparing responses for authority queries
4. Technical Skills
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Strong understanding of pharmacovigilance regulatory guidelines
🧑🎓 Eligibility & Qualifications
- M.Pharm (Pharmacology) – Mandatory
- Experience: 1–2 years in Pharmacovigilance
- Strong knowledge of RMP, PSUR, PBRER, and regulatory filings
- Excellent communication and documentation skills
- Note: Freshers are not eligible for this role.
⭐ Benefits of Working at Macleods Pharma
While the company has not specified benefits, typical advantages include:
- Competitive salary (industry-aligned for PV roles)
- Exposure to global regulatory markets
- Opportunity to work in a leading Indian pharmaceutical R&D setup
- Skill development through SOP/SGD training and PV process enhancements
📩 How to Apply
Eligible and interested candidates must email their updated resume to:
Email Subject Line: Application for RMP Drafter – Pharmacovigilance
