We are currently seeking a Associate Manager, Aggregate Reporting and Signal Management to join our growing team. Within this role you will:
- Lead the safety signal detection for a challenging product portfolio. Identify new safety signals early 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.
- Provide expert evaluation of results of post marketing and clinical development products’ signal detection activities at cross-functional team meetings: Product Safety Team, Safety Monitoring Team, Joint Safety Committees as appropriate.
- Collaborate productively with the safety leads for the respective products and, as a core member of the cross-functional Safety Monitoring Team, provide expert input for post marketing signal detection activities using internal and external spontaneous reporting databases.
- Provide expert input to safety team and Global Head of Safety Signal Detection. Perform database searches in external Health Authority databases (FAERS/Vigibase), analyzing and reporting the results.
- Perform QC checks of Health Authority database searches done by colleagues. Provide relevant inputs for enhancements of current systems and processes; Provide safety input as it relates to post marketing signal detection activities to safety documents, as well as ad hoc Health Authority queries.
- Act as Subject Matter Expert (SME) for post marketing and clinical development Safety Signal Detection (including participation in initiatives) and provide guidance on methodology used for automated signal detection to safety leads and cross-functional teams.
- Manage Eudravigilance database requests i.e. monitoring Eudravigilance for assigned products; Lead the training and mentoring of junior Safety Signal Colleagues and take an active part at the medical safety onboarding activities.
- Drive the development and update of Business Guidance documents and SOPs accordingly; Contribute to the development of new approaches of automated signal detection in internal/ external databases.
Desirable Skills and Experience
- 6+ years in drug development for a major pharmaceutical company
- 2 years’ experience in Patient Safety at an operational level or having held a medical position
- Experience in Quantitative Safety Signal Detection and Safety Signal Management related activities
- Experience in developing strategy in quantitative signal detection methods along with hands on experience in using Statistical tools
- Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics.
- Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
- Experience in preparing or contributing to preparation of safety assessments and regulatory reports involving safety information
- Experience with (safety or others) issue management.
- Experience conducting safety review meetings and SRC meetings