Macleods Pharma Hiring RMP Drafter in Pharmacovigilance in Mumbai for pharmacovigilance roles; check eligibility, job responsibilities, salary, and application process here.
Introduction
Macleods Pharmaceutical Ltd., one of India’s leading and fastest-growing research-driven pharmaceutical companies, is inviting applications for the role of RMP Drafter in its Pharmacovigilance (PV) – R&D Department based in Andheri, Mumbai. The company is known for its strong global market presence, high-quality product portfolio, and commitment to maintaining the highest standards in drug safety and regulatory compliance. With multiple approvals across Europe, the UK, India, and several Rest of the World (ROW) markets, Macleods continues to strengthen its PV and regulatory capabilities. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
The position of RMP Drafter plays a crucial role in the development and review of key safety documents such as PSURs, PBRERs, ACOs, and Risk Management Plans. This long-format article provides detailed information on the job role, responsibilities, required qualifications, benefits, and the step-by-step application process for interested candidates with 1–2 years of pharmacovigilance experience. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
About the Hiring Company – Macleods Pharmaceutical Ltd.
Established in 1986, Macleods Pharma has grown into a major pharmaceutical manufacturer with operations in more than 120 countries. The organization is known for its robust manufacturing practices, advanced research facilities, and strong presence in global regulatory markets. Its Pharmacovigilance and R&D department plays a vital role in ensuring drug safety compliance through continuous safety monitoring, risk assessment, and regulatory submissions. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
As the pharmaceutical industry continues to expand and regulatory authorities reinforce stricter safety requirements, the demand for skilled pharmacovigilance professionals—especially those proficient in aggregate report preparation and risk management planning—has risen sharply. The RMP Drafter role at Macleods aligns perfectly with this growing need and offers a strong career pathway for qualified candidates. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
Job Overview: RMP Drafter – Pharmacovigilance
The RMP Drafter position involves detailed preparation, drafting, and review of pharmacovigilance safety documents. Candidates with experience in PSUR/PBRER preparation, ACO drafting, and RMP documentation will find this a suitable and rewarding role. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
Job Highlights:
- Role: RMP Drafter – Pharmacovigilance
- Department: PV – R&D
- Company: Macleods Pharmaceutical Ltd.
- Location: Andheri East, Mumbai
- Experience Required: 1–2 years
- Qualification: M.Pharm (Pharmacology)
- Vacancies: 01
- Work Mode: On-site
- Salary Range: 4.2 LPA to 6.5 LPA
- Application Mode: Email
- Application Email: adityab@macleodspharma.com
This position is strictly suitable for candidates who already have a background in pharmacovigilance and have worked on safety documentation. Freshers should not apply. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
Why the Role of RMP Drafter Is Important
The RMP Drafter is a critical part of the PV team responsible for safety documentation essential for regulatory submissions. Pharmacovigilance requires detailed and accurate reporting to avoid compliance issues and ensure that the company meets the standards outlined by global authorities including the European Medicines Agency (EMA), MHRA (UK), CDSCO (India), and ROW regulatory bodies. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
RMP Drafters contribute to:
- Ensuring patient safety
- Identifying, evaluating, and minimizing risks
- Supporting global safety submissions
- Maintaining compliance with evolving regulatory guidelines
- Developing robust safety documentation
This makes the position both accountable and highly valuable for long-term career advancement in the PV domain.
Key Responsibilities of RMP Drafter
The RMP Drafter will handle end-to-end management of aggregate safety documents. Below is a detailed breakdown of the responsibilities associated with this position:
1. Reviewing and Drafting Safety Documents
The selected candidate will engage in reviewing and drafting a variety of regulatory safety documents, including:
- PSUR (Periodic Safety Update Report)
- PBRER (Periodic Benefit-Risk Evaluation Report)
- ACO (Addendum to Clinical Overview)
- RMP (Risk Management Plan)
These documents must be aligned with updated regulatory expectations for regions such as Europe, the UK, India, and ROW countries. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
2. Safety Report Planning and Organization
The role requires the planning and tracking of all safety documents through:
- Preparation of PSUR/PBRER submission calendars
- Maintenance of report timelines
- Allocation of writing or review tasks to internal team members
- Ensuring timely submission of reports to RA, LRP, or relevant regulatory authorities
Timeliness and accuracy are key requirements in pharmacovigilance documentation, making this responsibility vital. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
3. Ensuring Regulatory Compliance
The candidate must demonstrate a thorough understanding of regulatory guidelines and ensure compliance by:
- Drafting Standard Operating Procedures (SOPs)
- Preparing Standard Guideline Documents (SGDs)
- Updating existing SOPs and SGDs as per global PV requirements
- Ensuring alignment with EMA, MHRA, CDSCO, and international guidance
4. Handling Regulatory Queries
The candidate will be required to:
- Address queries raised by regulatory agencies
- Coordinate with internal teams to prepare accurate responses
- Ensure timely submission of clarifications and supporting documents
Strong document interpretation skills are required here.
5. Technical and Documentation Skills
Candidates must demonstrate proficiency in:
- Microsoft Word – report format and draft preparation
- Microsoft Excel – tracking calendars, datasets, and timelines
- Microsoft PowerPoint – training materials and presentations
- Understanding of global PV guidelines and document structure
These skills are essential for creating structured, compliant, and error-free safety reports.
Eligibility Criteria
To apply for the RMP Drafter role, the candidate must meet the following eligibility conditions:
- Qualification: M.Pharm (Pharmacology)
- Experience: 1–2 years in Pharmacovigilance
- Domain Expertise: Must have exposure to RMP drafting, PSUR/PBRER writing or review, and understanding of safety documentation
- Additional Skills:
- Strong written and verbal communication
- Attention to detail
- Document review and formatting skills
- Understanding of regulatory expectations
Note: Freshers will not be considered for this position, as hands-on experience is mandatory.
Benefits of Working at Macleods Pharma
Though the exact benefits for this role are not officially listed, Macleods Pharma typically offers: Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
1. Competitive Salary
The salary range of ₹4.2 LPA to ₹6.5 LPA is in line with industry compensation for PV professionals with 1–2 years of experience.
2. Exposure to Global Regulatory Markets
The selected candidate will gain experience working with regulatory guidelines from:
- Europe
- United Kingdom
- India
- ROW markets
This exposure is extremely beneficial for long-term career growth in pharmacovigilance.
3. Professional Growth Opportunities
Employees often get opportunities to:
- Participate in drafting and training on SOPs
- Work with cross-functional teams
- Engage in regulatory discussions
- Advance to senior PV or regulatory writing roles
4. Learning Environment
The position provides continuous learning through interactions with:
- PV quality teams
- Regulatory Affairs
- Clinical research and R&D divisions
How to Apply
Candidates who meet the eligibility criteria can apply through the official email mentioned below. Make sure to follow the instructions carefully for a successful application. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
Step-by-Step Application Process
- Prepare an updated resume highlighting your experience in PSUR, PBRER, ACO, and RMP documentation.
- Save your resume as a PDF file.
- Write a professional email expressing your interest in the RMP Drafter position.
- Use the subject line exactly as prescribed:
Application for RMP Drafter – Pharmacovigilance - Attach your resume to the email.
- Send your application to the official recruiter email:
Email for Sending Applications:
This job opening is available for a limited time, so candidates are advised to apply at the earliest. Macleods Pharma Hiring RMP Drafter in Pharmacovigilance
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
