Drug Safety Associate
Biopharmaceuticals / Biotherapeutics
- Job Level:
$70,000 - $80,000
We are currently seeking a Drug Safety Associate for day-to-day managerial oversight and processing of clinical SAE reports, liaison with other functions and vendors, maintenance of SOPs and Work Practice Guides, tracking compliance with safety reporting to regulatory authorities, and assistance with database maintenance activities.
- 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, pharmacy or nursing.
Experience & Skills Required
- Minimum of 10 years’ experience in Drug Safety/ Pharmacovigilance processes and procedures
- Minimum of 5 years’ experience with ARGUS Drug Safety database or other Safety databases
- 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%)