Senior Drug Safety Assistant
Interact with therapeutic teams to customize standard letters as necessary
- Contribute to assessment of the timeliness of US follow-up letter request distributions against applicable guidelines and procedures
- Archiving of adverse event source documents as needed, DSS Outbound queries and Follow Up Letter correspondence
- Quality assurance of legacy case file order for DSS source documents of individual case safety reports
- Assure accuracy of tracking of archiving of adverse event report
- Administer inter-departmental problem-solving tactics, reconciling discrepancies daily and provide support to physicians, follow-up personnel and custodians
- Responsible for retrieving litigation and normal business audit request from off-site storage
- Responsible for Individual ICSR indexing folder stored in a shared drive. Responsible for Archival of FDA 15-Day reports
- Responsible for printing and mailing follow-up letter to HCP, Consumer and letter to other company/ faxing or send via email address.
- Lead /organized and supervised ICSR files to off-site 65000 case files April 2010 - July 31, 2010
- Responsible for coordinating and shipping ICSR to off-site every three months.