Pharmacovigilance Officer
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 in Pharmacovigilance. 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:
- Supervise pharmacovigilance case management outsourced to assigned platform(s)
- Respond to case-related emails and inquiries from external service providers
- Monitor case processing timelines and investigate any delays in reporting or transmission
- Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
- Support the review and validation of clinical study case narratives for inclusion in study reports
- Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
- Oversee reconciliation of cases with clinical databases managed by outsourced providers
- Collaborate closely with cross-functional and global teams to ensure compliance and data integrity
Requirements