Pharmacovigilance – Aggregate Reporting & Signal Detection We are looking for experienced Pharmacovigilance professionals with expertise in Aggregate Safety Reporting, Signal Detection and Risk Management.

Key Responsibilities
• Review and evaluate aggregate safety reports, including PSURs, PBRERs, DSURs, CARs and PADERs.
• Review and evaluate Signal Detection Reports and Risk Management Plans (RMPs).
• Ensure compliance with global regulatory guidelines and reporting requirements.
• Identify emerging safety concerns, trends and patterns through aggregated safety data.
• Collaborate with cross-functional teams to support risk management and safety signal detection activities.
• Author and review signal detection activity reports.
• Apply statistical and data-mining techniques to identify potential safety signals.




• Perform signal validation and support signal assessment activities. Required Qualifications &

Skills:
• B.
Pharm / M.
Pharm / Pharm.
D.
• 4–8 years of relevant Pharmacovigilance experience.
• Strong knowledge of aggregate reporting and signal management.
• Understanding of ICH guidelines, EMA GVP and FDA regulatory requirements.
• Knowledge of statistical signal detection methodologies.
• Solid analytical, documentation and communication skills.

Location:
Bengaluru, Karnataka Mode of Work: Work from Office

Experience:
4–8 Years Qualification: B.
Pharm / M.
Pharm / Pharm.
D

📌 Associate (Bengaluru)
🏢 Pivot Path
📍 Bengaluru