Pharmacovigilance Specialist
posted by: spj_bot
Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
Key responsabilities:
- Perform the medical review and assessment of sensitive and complex pharmacovigilance cases based on source documents and medical records.
- Analyze case documentation to identify, extract and evaluate relevant medical information in accordance with applicable procedures and guidelines.
- Contribute to the medical and scientific evaluation of safety cases, ensuring the completeness, consistency and accuracy of collected data.
- Collaborate closely with Pharmacovigilance Operations teams to support case processing activities.
- Review documentation to identify potential duplicate cases and support their assessment in collaboration with PV teams.
- Identify potential adverse events and ensure their timely communication for entry into the global pharmacovigilance database.
- Assess and communicate significant new safety information and follow-up data arising from additional source documentation.
- Ensure compliance with pharmacovigilance regulations, internal procedures and quality standards.
- Support continuous improvement initiatives related to medical case review and pharmacovigilance processes.