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.
- Robust knowledge of aggregate reporting and signal management.
- Understanding of ICH guidelines, EMA GVP and FDA regulatory requirements.
- Knowledge of statistical signal detection methodologies.
- Strong 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