Macleods Pharmaceuticals Hiring PBRER Reviewer & RMP Drafter | Pharmacovigilance Jobs in Mumbai 2026
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(Macleods Pharmaceuticals Hiring PBRER Reviewer & RMP Drafter) |
Introduction
Professionals looking for Pharmacovigilance jobs in Mumbai have an excellent opportunity to join Macleods Pharmaceuticals, one of India's leading pharmaceutical companies. The organization is currently recruiting experienced candidates for PBRER Reviewer and RMP Drafter positions within its Pharmacovigilance Department.
This recruitment drive is ideal for M.Pharm graduates who have experience in aggregate safety reporting, PSUR preparation, PBRER review, Risk Management Plans (RMP), and global regulatory compliance activities. Selected candidates will gain exposure to international pharmacovigilance projects covering Europe, the UK, India, and other global markets.
About the Company
Macleods Pharmaceuticals is a well-established pharmaceutical company known for its presence in multiple therapeutic segments and global markets. The company focuses on research-driven pharmaceutical development, manufacturing, and commercialization of quality healthcare products.
With a strong regulatory footprint across various international markets, Macleods continues to expand its pharmacovigilance and drug safety operations to support patient safety and regulatory compliance worldwide. Working with Macleods provides professionals with an opportunity to participate in global safety reporting programs and regulatory documentation activities.
Job Overview Summary
The Pharmacovigilance Department at Macleods Pharmaceuticals is seeking professionals with hands-on experience in PBRER, PSUR, RMP, and Aggregate Clinical Overview review activities.
Selected candidates will work closely with safety teams, regulatory affairs professionals, and global stakeholders to ensure the timely submission of safety reports while maintaining compliance with international pharmacovigilance requirements.
Vacancy Details
Company Name: Macleods Pharmaceuticals
Department: Pharmacovigilance
Positions Available:
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PBRER Reviewer
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RMP Drafter
Job Type: Full-Time, Permanent
Location: Andheri East (MIDC), Mumbai, Maharashtra
Qualification: M.Pharm
Experience Required: 1–2 Years
Industry: Pharmaceutical & Life Sciences
Job Role Explanation
The selected candidates will play an important role in pharmacovigilance operations and aggregate safety reporting.
Key responsibilities may include:
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Reviewing and evaluating Periodic Safety Update Reports (PSURs).
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Conducting quality reviews of Periodic Benefit-Risk Evaluation Reports (PBRERs).
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Drafting and updating Risk Management Plans (RMPs).
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Reviewing Aggregate Clinical Overview (ACO) documents.
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Managing submission schedules and reporting timelines.
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Coordinating with Regulatory Affairs teams for submissions.
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Supporting global safety reporting activities.
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Responding to regulatory authority queries.
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Preparing SOPs and guidance documents.
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Assisting in pharmacovigilance compliance initiatives.
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Conducting internal training programs.
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Maintaining documentation according to regulatory requirements.
This role is highly suitable for candidates seeking long-term growth in Drug Safety, Aggregate Reporting, Regulatory Writing, and Pharmacovigilance Operations.
Eligibility Criteria
Candidates applying for these positions should possess:
Educational Qualification
Experience Required
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1–2 years of experience in Pharmacovigilance.
Hands-on Experience In
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PBRER
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PSUR
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RMP
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Aggregate Safety Reporting
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Aggregate Clinical Overview (ACO)
Additional Requirements
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Good understanding of global pharmacovigilance regulations.
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Strong documentation skills.
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Medical writing experience.
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Ability to manage regulatory timelines.
Skills Required
Successful candidates should have the following professional skills:
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Pharmacovigilance Operations
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Drug Safety Management
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Aggregate Report Review
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PBRER Review
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PSUR Preparation
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RMP Drafting
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Regulatory Documentation
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Medical Writing
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Signal Evaluation
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Global Safety Reporting
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SOP Writing
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Risk Assessment
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Quality Compliance
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Regulatory Communication
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Time Management
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Cross-functional Collaboration
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Microsoft Office Skills
Salary Estimate
Although the company has not officially disclosed salary details, professionals with 1–2 years of experience in aggregate safety reporting and pharmacovigilance generally receive compensation in the range of:
Estimated Salary: ₹5.5 LPA – ₹9.5 LPA
Actual compensation may vary based on:
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Relevant experience
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Technical expertise
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Interview performance
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Current compensation structure
Interview Details
As per the available information:
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Interview Mode: Company Selection Process
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Department: Pharmacovigilance
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Location: Mumbai
Shortlisted candidates will be contacted directly by the recruitment team regarding interview schedules and assessment rounds.
Required Documents
Candidates should keep the following documents ready before applying:
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Updated Resume/CV
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Educational Certificates
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M.Pharm Degree Certificate
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Experience Certificates
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Current Salary Details
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Last Three Months Salary Slips
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Notice Period Information
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Government ID Proof
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Passport Size Photograph
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Pharmacovigilance Project Details (if applicable)
Job Location
Andheri East (MIDC), Mumbai, Maharashtra, India
Mumbai remains one of India's major pharmaceutical and pharmacovigilance hubs, offering significant career opportunities in drug safety, regulatory affairs, medical writing, and clinical research.
Why Join Macleods Pharmaceuticals?
Working with Macleods Pharmaceuticals can provide:
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Exposure to global pharmacovigilance projects.
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Experience with EU, UK, India, and ROW regulatory submissions.
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Career growth in aggregate reporting.
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Opportunities in drug safety and risk management.
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Professional development in international regulatory compliance.
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Collaboration with experienced pharmacovigilance professionals.
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Strong learning environment for regulatory reporting activities.
How to Apply
PBRER Reviewer Application
Apply through the official job posting and submit your updated profile.
RMP Drafter Application
Interested candidates can apply through the official recruitment portal and complete the application process by providing up-to-date professional details.
Candidates should ensure that their CV highlights experience in:
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PBRER
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PSUR
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RMP
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Aggregate Safety Reporting
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Pharmacovigilance
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Regulatory Documentation
Frequently Asked Questions (FAQs)
Q1. What qualifications are required for Macleods Pharmacovigilance jobs?
Candidates must possess an M.Pharm degree.
Q2. How much experience is required?
Applicants should have 1–2 years of relevant experience in Pharmacovigilance.
Q3. Which positions are currently open?
The company is hiring for:
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PBRER Reviewer
-
RMP Drafter
Q4. Is experience in PSUR and PBRER mandatory?
Candidates with hands-on experience in PSUR, PBRER, and aggregate reporting will have a strong advantage.
Q5. What is the job location?
The positions are based in Andheri East (MIDC), Mumbai.
Q6. Is this role suitable for freshers?
No. The company is specifically seeking candidates with 1–2 years of Pharmacovigilance experience.
Q7. What career growth opportunities are available?
Professionals can progress toward Senior Drug Safety Associate, Pharmacovigilance Specialist, Aggregate Reporting Lead, Safety Scientist, and Regulatory Affairs roles.
Q8. What software skills are preferred?
Microsoft Word, Excel, and PowerPoint proficiency is preferred, along with pharmacovigilance documentation expertise.
Final Conclusion
Macleods Pharmaceuticals' latest Pharmacovigilance recruitment drive presents an excellent opportunity for M.Pharm professionals looking to advance their careers in aggregate safety reporting, PBRER review, and Risk Management Plan preparation. With exposure to international regulatory submissions and global safety reporting standards, these positions can provide valuable experience for professionals seeking long-term growth in the pharmacovigilance and drug safety domain.
Interested candidates should review their eligibility, update their resumes, and apply as early as possible to maximize their chances of selection.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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