Sun Pharmaceutical Industries Ltd. is hiring for Pharmacovigilance – PSUR & Aggregate Reporting roles in Gurugram, India. This opportunity is ideal for MBBS/MD professionals with expertise in PSUR/PBRER, aggregate safety reporting, and signal detection.

If you are looking to advance your career in pharmacovigilance aggregate reporting, risk characterization, and regulatory safety documents, this role offers strong exposure to innovator products and NCEs (New Chemical Entities).

Key Responsibilities – Pharmacovigilance PSUR Role

• Analyze Individual Case Safety Reports (ICSRs) in aggregate context
• Perform causality assessment, seriousness & expectedness evaluation
• Conduct risk characterization and benefit-risk evaluation
• Prepare and review PSUR / PBRER reports
• Perform scientific literature review for safety signals
• Develop summary tabulations and cumulative safety data
• Write special situation case narratives for PSUR
• Identify Emerging Safety Issues (ESI) / Significant Safety Issues (SSI)
• Evaluate safety notifications and regulatory queries
• Review clinical trial protocols & safety management plans (SMP)
• Support regulatory responses and aggregate reporting projects

Eligibility Criteria & Qualifications

• Education: MBBS or MD (Mandatory)
• Strong expertise in:
  • Pharmacovigilance aggregate reporting (PSUR/PBRER, DSUR, PADER)
  • MedDRA coding
  • Causality assessment methodologies
  • ICSR analysis and signal detection
• Understanding of:
  • Regulatory requirements for NCEs / innovator products
  • Risk Management Plans (RMP)
  • Clinical study protocols (PV perspective)

Preferred Skills

• Pharmacovigilance PSUR jobs India
• Aggregate reporting PV jobs
• Drug safety physician jobs India
• Signal detection & risk management
• Regulatory safety writing (PSUR, DSUR, PADER)
• Medical review in pharmacovigilance

Salary & Benefits

• Salary: ₹10 LPA – ₹22 LPA (Estimated based on experience & market standards)
• Work on innovator drugs and global safety databases
• Exposure to global regulatory authorities (EMA, FDA, MHRA)
• Career growth in drug safety, risk management, and aggregate reporting

Why This Role is Important

This Pharmacovigilance PSUR job plays a critical role in ensuring drug safety compliance and benefit-risk evaluation across global markets. Professionals in this role directly contribute to regulatory decision-making and patient safety worldwide.

How to Apply

Application Link