Manager Drug Safety
Posted on Feb 5, 2019 by HumanEdge
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 a Bachelor Degree, preferably in a health or life science discipline such as medicine, nursing or pharmacy.
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
Ability to travel, if necessary (less than 5%)
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