Key Responsibilities:
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.
