Macleods Pharmaceuticals is hiring a Safety Data Analyst specializing in Signal Detection for its Pharmacovigilance Department in Mumbai. This role is ideal for professionals with 2–5 years of experience in pharmacovigilance operations, signal detection, and regulatory compliance.
Key Responsibilities:
1. Signal Detection & Safety Data Analysis
- Perform signal detection analyses and prepare reports (cumulative reviews, issue-based assessments).
- Evaluate listedness, seriousness, and causality of ICSRs (Individual Case Safety Reports).
- Review Vigilance Designated Medical Events (DMEs) and published literature.
- Use EudraVigilance Data Analysis System (EVDAS) for safety signal evaluation.
- Draft Signal Detection Reports, Risk Management Plans (RMPs), PSURs, and PADERs.
2. Literature & Safety Data Management
- Conduct literature screening and ensure timely documentation.
- Track safety data from post-marketing studies (SAEs/AEs).
- Perform Quality Control (QC) checks for ICSRs in safety databases.
- Update SOPs (Standard Operating Procedures) and Work Instructions (WIs).
- Support internal audits and regulatory inspections.
3. Stakeholder Coordination
- Collaborate with PMS teams, CROs, and regulatory bodies.
- Ensure compliance with ICH, GVP, and PRAC guidelines.
About Macleods Pharmaceuticals
Macleods Pharmaceuticals is a leading Indian pharmaceutical company with a strong global presence. Known for its high-quality generics and innovative drug formulations, Macleods specializes in therapeutics for infectious diseases, cardiology, and critical care.
The company has a robust pharmacovigilance (PV) system, ensuring drug safety and compliance with global regulatory standards (EMA, FDA, WHO).
Desired Skills & Qualifications
✅ Education: B.Pharm / M.Pharm / PharmD
✅ Experience: 2–5 years in pharmacovigilance (signal detection, literature review, case processing)
✅ Technical Skills:
- Proficiency in EudraVigilance, Argus, or other safety databases
- Strong data analysis & Microsoft Office skills
- Knowledge of ICH-GCP, GVP, and regulatory guidelines
✅ Soft Skills: - Excellent communication & teamwork abilities
- Problem-solving & attention to detail
How to Apply?
If you meet the qualifications and are interested in this Signal Detection Analyst role, send your updated resume to:
📩 Email: adityab@macleodspharma.com
📍 Location: Andheri, Mumbai
