Are you a skilled pharmacovigilance professional with a keen eye for regulatory compliance? Macleods Pharmaceuticals Ltd., one of India’s leading global pharmaceutical companies, is inviting applications for two vital positions in its Pharmacovigilance Department (R&D) at Andheri, Mumbai.
These openings — Aggregate Report Reviewer and Website Review & Compliance Report Specialist — offer an opportunity to contribute to global drug safety and compliance operations within a reputed organization.
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🔹 Position 1: Aggregate Report Reviewer
Roles & Responsibilities
- Conduct quality review of PSUR, PBRER, ACO, and RMP for Europe/UK, India, and ROW markets.
- Prepare and manage PSUR/PBRER/ACO calendars and allocate tasks to the team.
- Track reports to ensure timely submission to regulatory authorities.
- Draft, review, and train team members on SOPs and SGDs as per updated guidelines.
- Handle regulatory queries and responses efficiently.
Technical Skills
- Proficiency in Microsoft Word, Excel, and PowerPoint.
Qualifications
- M.Pharm (Pharmacology)
- Experience: 1–2 years in reviewing aggregate safety reports.
- Work Mode: On-site (Andheri, Mumbai).
- Freshers: Not eligible.
🔹 Position 2: Website Review & Compliance Report Activity
Roles & Responsibilities
- Perform daily website reviews for regions like Europe, UK, India, WHO, South Africa, Ukraine, etc.
- Identify and share safety-related updates with relevant teams (Case Processing, PSUR, Signal).
- Update SOPs per guideline revisions.
- Coordinate with QPPV and LRP for training and query resolution.
- Maintain archival of documents and emails as per process requirements.
- Collect data from multiple PV teams to draft compliance reports.
- Conduct compliance meetings with QPPV and manage minutes of meeting (MOM).
- Update and maintain product lists based on approval or withdrawal status.
Desired Skills & Competencies
- Knowledge of GVP Module, MHRA, EU/UK/USFDA, and India/ROW PV guidelines.
- Strong written and verbal communication.
- Good organizational and time management skills.
- In-depth knowledge of PSMF, ICSR, PSUR, and RMP processes.
Qualifications
- M.Pharm (Pharmacology/Pharmaceutics)
- Experience: 1–2 years in pharmacovigilance operations or compliance.
- Work Mode: On-site (Andheri, Mumbai).
- Freshers: Not eligible.
💼 Why Join Macleods Pharmaceuticals?
- Opportunity to work with a top-ranked global pharmaceutical company.
- Exposure to international regulatory frameworks (EU, UK, India, ROW).
- Collaborative and growth-driven work environment.
- Competitive compensation and learning opportunities in drug safety and compliance.
📩 Application Process
Interested candidates can email their updated resume to:
📧 adityab@macleodspharma.com
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