Pharmacovigilance Project 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.
In this role, you will combine operational PV expertise with project coordination responsibilities to ensure patient safety and regulatory compliance throughout the product lifecycle.
Main Responsibilities:
- Manage and oversee pharmacovigilance case processing activities from receipt to reporting.
- Collect, assess, document, and follow up on adverse event reports from multiple sources.
- Perform quality review and medical consistency checks of safety cases prior to submission.
- Support local signal detection activities and contribute to safety monitoring initiatives.
- Participate in literature surveillance and regulatory intelligence activities.
- Contribute to periodic safety reports and monthly PV activity reporting.
- Collaborate with Global Safety, Medical Information, Clinical Teams, and external partners.
- Maintain complete and inspection-ready PV documentation, tracking, and archiving.
- Support the review and continuous improvement of local PV procedures and processes.
- Act as a key PV contact, ensuring clear communication, escalation, and stakeholder management.
Requirements