Safety Signal Detection and Triage:
- Perform safety signal detection and triage activities for a challenging product portfolio.
- Identify new safety signals based on review and comprehensive medical evaluation of technical hits in post-marketing spontaneous reporting databases, analyzing single case reports as well as aggregate data available.
Expert Evaluation:
- Provide expert evaluation of results of post-marketing signal detection activities at cross-functional team meetings, including Safety Review Meetings and Joint Safety Committees as appropriate.
Collaboration:
- Collaborate productively with the safety leads for the respective products.
- Serve as a core member of the cross-functional Signal Management Team, providing expert input for post-marketing signal detection activities using internal and external spontaneous reporting databases.
Database Searches and Analysis:
- Perform database searches in external Health Authority databases (FAERS, Vigibase, iDAP, DAEN), analyzing and reporting the results.
- Perform QC checks of Health Authority database searches done by colleagues.
EudraVigilance Management:
- Manage EudraVigilance database requests, including monitoring EudraVigilance for assigned products.
- Provide support in training and mentoring junior Safety Signal Colleagues.
Development of Guidance Documents:
- Drive the development and update of Business Guidance documents and SOPs.
- Contribute to the development of new approaches for automated signal detection in internal/external databases.
Qualifications:
- Bachelor’s degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). Advanced degree preferred.
- Experience in pharmacovigilance, drug safety, or related field, with a focus on safety signal detection and triage.
- Knowledge of post-marketing spontaneous reporting databases and Health Authority databases (FAERS, Vigibase, iDAP, DAEN).
- Strong analytical and problem-solving skills with the ability to evaluate and interpret complex safety data.
- Demonstrated ability to collaborate effectively with cross-functional teams and provide expert input in a matrix environment.
- Experience in managing EudraVigilance database requests and conducting QC checks of database searches.
- Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.
- Excellent written and verbal communication skills.
- Proficiency in developing and updating SOPs and Business Guidance documents.
