Macleods Hiring for Aggregate Report Reviewer in PV

Macleods Pharmaceuticals Ltd. has an opening for an Aggregate Report Reviewer in its Research and Development (R&D) department in Andheri, Mumbai. The position requires 1–2 years of experience in reviewing aggregate reports. Candidates with an M. Pharm in Pharmacology and knowledge of Microsoft Office applications are eligible to apply.

Freshers are not eligible for this opportunity.

Job Details

Position: Aggregate Report Reviewer

The selected candidate will be responsible for quality review, preparation, tracking, and regulatory compliance activities related to aggregate safety reports, including PSUR, PBRER, ACO, and RMP.

Roles and Responsibilities

• Conduct quality reviews of PSUR, PBRER, ACO, and RMP reports for Europe/UK, India, and ROW countries.
• Prepare PSUR/PBRER/ACO calendars and allocate reports to the team.
• Track reports to ensure timely submission to Regulatory Affairs (RA), Local Responsible Persons (LRPs), or other respective authorities.
• Prepare and provide training on Standard Operating Procedures (SOPs) and SGD as per guideline requirements.
• Handle queries from agencies and authorities and prepare responses.

Eligibility and Qualifications

Candidates applying for the Aggregate Report Reviewer position must meet the following requirements:

• Educational Qualification: M. Pharm in Pharmacology.
• Work Experience: 1–2 years of experience in aggregate report review.
• Candidate Type: Experienced professionals only. Freshers should not apply.

Required Technical Skills

• Microsoft Word
• Microsoft PowerPoint
• Microsoft Office

Experience in reviewing PSUR, PBRER, ACO, and RMP reports is required.

How to Apply for Macleods Pharmaceuticals Jobs

Interested and eligible candidates can email their updated resumes to adityab@macleodspharma.com.

Applicants should include the following details in their application:

• Total Experience
• Current CTC
• Expected CTC
• Notice Period
• Current Working Location