Macleods Pharmaceuticals has announced exciting hiring opportunities for experienced Pharmacovigilance professionals in Mumbai. The company is recruiting for PBRER Reviewer and RMP Drafter positions within its Pharmacovigilance Department. Candidates with 1โ2 years of experience in Periodic Benefit-Risk Evaluation Reports (PBRER), Risk Management Plans (RMP), PSUR, and Aggregate Safety Reporting are encouraged to apply.
If you’re looking for Pharmacovigilance jobs in Mumbai, PBRER Reviewer jobs in India, or RMP Drafter vacancies, this opportunity offers excellent exposure to global regulatory safety reporting across Europe, UK, India, and Rest of World (ROW) markets.
Job Details
| Particular | Details |
|---|---|
| Company | Macleods Pharmaceuticals |
| Positions | PBRER Reviewer & RMP Drafter |
| Department | Pharmacovigilance |
| Experience | 1โ2 Years |
| Employment Type | Full-Time, Permanent |
| Location | Andheri East (MIDC), Mumbai |
| Education | M.Pharm (Pharmacy) |
| Industry | Pharmaceutical & Life Sciences |
Key Responsibilities
Selected candidates will be responsible for:
- Perform quality review of PSUR, PBRER, Aggregate Clinical Overview (ACO), and Risk Management Plans (RMP).
- Review safety reports for Europe, UK, India, and ROW regulatory markets.
- Prepare and maintain PSUR/PBRER/ACO submission calendars.
- Allocate reports to team members and monitor submission timelines.
- Ensure timely submissions to Regulatory Affairs (RA), Local Responsible Person (LRP), and relevant health authorities.
- Prepare Standard Operating Procedures (SOPs) and Standard Guidance Documents (SGDs).
- Conduct internal training on pharmacovigilance guidelines and reporting procedures.
- Handle agency and regulatory authority queries.
- Draft responses for health authority questions.
- Support compliance with global pharmacovigilance regulations.
Required Qualifications
Applicants should possess:
- M.Pharm in Pharmacy.
- 1โ2 years of Pharmacovigilance experience.
- Hands-on experience in:
- PBRER
- PSUR
- RMP
- Aggregate Safety Reporting
- ACO
- Knowledge of global pharmacovigilance regulations.
- Good documentation and medical writing skills.
- Strong communication abilities.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Ability to work with regulatory timelines.
Preferred Skills
- Pharmacovigilance
- Drug Safety
- Pharmacology
- Aggregate Report Review
- Risk Management Plans (RMP)
- PSUR
- PBRER
- SOP Writing
- Regulatory Compliance
- Medical Writing
- Safety Reporting
- Signal Evaluation
- Global Regulatory Reporting
Why Join Macleods Pharmaceuticals?
Working with Macleods Pharmaceuticals offers:
- Opportunity to work on global pharmacovigilance projects.
- Exposure to EU, UK, India, and ROW regulatory submissions.
- Experience with aggregate safety reporting.
- Career growth in Drug Safety and Regulatory Affairs.
- Collaborative work environment.
- Learning opportunities in international pharmacovigilance guidelines.
Who Should Apply?
This opportunity is ideal for professionals with experience in:
- Pharmacovigilance
- Drug Safety
- Medical Writing
- Aggregate Reporting
- Regulatory Affairs
- Clinical Safety
- Benefit-Risk Evaluation Reports
- Risk Management Plans
Location
Mumbai (Andheri East โ MIDC), Maharashtra, India
How to Apply
Application Link For PBRER Reviewer
Application Link For RMP Drafter
