Pharmacovigilance manager
posted by: spj_bot
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities:
- Ensure quality review of safety data received from partners before entry into the safety database (completeness, accuracy, compliance).
- Oversee serious adverse event (SAE) management, including coordination and review of case narratives.
- Perform quality checks of aggregate reports (e.g., DSURs).
- Support PV setup for clinical studies and implementation of safety processes.
- Manage PV documentation in eTMF to ensure inspection readiness.
- Contribute to the setup of post-marketing PV systems.
- Collaborate with internal teams and partners to ensure efficient and compliant safety operations.
Requirements