Macleods Pharmaceuticals Ltd. has announced a new hiring opportunity for the position of Aggregate Report Reviewer (PBRER) in its Pharmacovigilance Department at Andheri, Mumbai. Candidates with an M.Pharm (Pharmacology) degree and 1-2 years of experience in Aggregate Report Review are encouraged to apply.
This Pharmacovigilance job is an excellent opportunity for professionals experienced in PSUR, PBRER, Risk Management Plans (RMP), Aggregate Reports, and Drug Safety looking to advance their careers with one of India’s leading pharmaceutical companies.
Job Details
| Particular | Details |
|---|---|
| Position | Aggregate Report Reviewer (PBRER) |
| Department | Pharmacovigilance |
| Company | Macleods Pharmaceuticals Ltd. |
| Location | Andheri, Mumbai, Maharashtra |
| Experience | 1-2 Years |
| Qualification | M.Pharm (Pharmacology) |
| Employment Type | Full-Time |
The selected candidate will be responsible for:
- Quality review of PSUR, PBRER, ACO, and Risk Management Plans (RMP) for Europe, UK, India, and ROW markets.
- Preparation of PSUR, PBRER, and ACO submission calendars.
- Allocation of aggregate reports to the Pharmacovigilance team.
- Tracking report timelines to ensure timely submission to Regulatory Affairs (RA), Local Responsible Person (LRP), and regulatory authorities.
- Preparation and updating of SOPs and Standard Guidance Documents (SGDs) according to regulatory guidelines.
- Handling regulatory authority queries and preparing responses.
- Supporting compliance with global Pharmacovigilance regulations.
Applicants should possess:
- M.Pharm in Pharmacology.
- 1-2 years of Aggregate Report Review experience.
- Experience reviewing PSUR, PBRER, ACO, or RMP documents.
- Strong understanding of Pharmacovigilance regulations.
- Excellent written communication skills.
- Proficiency in Microsoft Word, PowerPoint, and Microsoft Office.
- Aggregate Report Writing
- PBRER Review
- PSUR Review
- Risk Management Plan (RMP)
- Regulatory Compliance
- Pharmacovigilance
- Drug Safety
- Medical Writing
- SOP Preparation
- Global Regulatory Guidelines
Based on current Pharmacovigilance market trends in Mumbai, the expected annual CTC for this role is approximately:
₹5.5 LPA – ₹8.0 LPA
Actual compensation may vary depending on experience, technical expertise, and interview performance.
Joining Macleods Pharmaceuticals offers professionals an opportunity to:
- Work on global Pharmacovigilance projects.
- Gain experience with Europe, UK, India, and ROW regulatory requirements.
- Develop expertise in Aggregate Report Review.
- Build a long-term career in Drug Safety and Regulatory Affairs.
- Work with one of India’s leading pharmaceutical organizations.
- Freshers are not eligible for this position.
- Candidates must mention the following subject line while applying:
Subject: Aggregate Report Reviewer – PBRER
Interested and eligible candidates can send their updated resume to:
Email: adityab@macleodspharma.com
Please mention “Aggregate Report Reviewer – PBRER” in the email subject line.