Sr. Specialist, Case Management Vendor Oversight, Global Patient Safety & Risk Management
SRG is recruiting a Sr. Specialist, Case Management Vendor Oversight, Global Patient Safety & Risk Management to support a growing and exciting Biotech company based in Cambridge, MA.
The Senior Specialist, Case Management Vendor Oversight, under Global Safety Operations, will be responsible for assisting the Global Patient Safety & Risk Management medical staff in the operational oversight of global pharmacovigilance activities of investigational and marketed products.
Summary of Key Responsibilities:
- Able to work with external service providers and vendors to support quality and timely processing of adverse events from clinical trial and spontaneous sources.
- Perform timely monitoring of workflow and reporting parameters to ensure compliance with regulations and performance metrics.
- Support the follow-up activities needed to perform due diligence activities for spontaneous reports.
- Review processed cases to ensure case quality from an operational perspective.
- Interface with the Quality Operations Department to support appropriate handling of Product Quality Complaints associated with adverse events.
- Coordinate and execute reconciliation of safety data with different stakeholders
- Academic degree in biological or natural science or health care discipline (e.g. BSN, NP, Pharm D, MSc) required.
- Minimum 3 years relevant experience (including industry experience) with a working knowledge of drug safety and risk management. drug development, ICH and FDA regulatory requirements, and standard medical coding thesauri (MedDRA, WHO DRUG).
- Working knowledge of applicable clinical trial safety regulations and post marketing regulations.
- Demonstrated ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including advanced understanding and application of medical concepts and terminology).
- Demonstrated ability to be highly collaborative and effective in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, Biostatistics and Regulatory), as well as with external colleagues for partnered products.
- Excellent written and verbal communication skills. Knowledge of drug development process.
- Critical thinking and ability to interpret case information.
- Strong organizational skills, including the ability to prioritize independently with minimal supervision.
- Experience with overseeing and coordinating work with external vendors.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
your application has been submitted