Senior Manager of Global Patient Safety
7 days ago
The Senior Manager of Global Patient Safety will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This role involves safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.
Key Responsibilities
- Complete signal detection activities in line with approved safety surveillance plans
- Perform signal evaluation for any identified signals and author safety evaluation reports
- Manage preparation and review of safety documents, including DSUR, PSUR, RMP, and responses to health authority queries
- Prepare and deliver presentations at Signal Management Team meetings and participate in clinical study team meetings for assigned compounds
- Participate in other risk management activities as appropriate for assigned compounds
Requirements
- Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
- Ability to work with a safety system database for purposes of medical case review and simple queries
- Proactive and self-disciplined, with the ability to meet deliverables and effectively use time and prioritize
- Effective communication (verbal and written) of safety findings
Education and Experience
- Minimum Master's, PhD, or PharmD degree
- 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority
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