• Manage day-to-day processing and archiving of clinical SAE reports in the safety database
• Perform SAE data entry and prepare case narratives
• Maintain SAE document filing system
• Perform oversight of CRO’s Clinical SAE management
• Assist in the development, update and review of Standard Operating Procedures (SOP), Work Practice Guides (WPG), Work flow, forms, training materials, etc.
• Actively participate in activities pertaining to safety database maintenance
• Actively contribute to and participate in the review of documents related to clinical trial and data management.
• Review and provide input into the development of project Safety Management Plans as required
• Coordinate preparation of aggregate safety reports
• Coordinate with other functions and vendors for timely completion and review of reports and other safety matters
• Serve as primary contact for SAE reconciliation with Data Management, Clinical Operations and CROs.
• Participate in Safety Assessment Committee activities
• Maintain proficient knowledge of applicable regulations, guidelines and guidance pertaining to safety reporting
• Other duties as assigned by Head of Drug Safety & Pharmacovigilance
• Minimum of 10 years’ experience in Drug Safety/ Pharmacovigilance processes and activities
• Minimum of 5 years’ experience with ARGUS Drug Safety database or other Safety databases
• Prior Drug Safety managerial experience highly desired.
• Demonstrated ability to multi-task
• Working knowledge of FDA and ICH regulations and guidelines pertaining to safety reporting and clinical trial management
• Excellent communication (written and spoken) and interpersonal skills
Minimum of a Bachelor Degree, preferably in a health or life science discipline such as medicine, nursing or pharmacy.
Ability to travel, if necessary (less than 5%)
Location: Stamford, CT