Patient Safety Operations Associate
Delaware All, DE
Provides accurate and timely US regulatory submissions preparation and submission of reports meeting US
FDA expedited reporting criteria to the FDA, including requesting literature articles. Prepares and ensures
accurate regulatory submissions of IND cross-reporting SUSARs to FDA. Prepares the US Investigator Safety
Letters to the ISL Administration group for onward distribution to the US Investigators. Ensures monthly
reconciliation of AE data exchanged between US vendors and for the US Licensing Agreements. Manages the
US Patient Safety mailbox for AE reports and queries.
Individual in this role carries out a range of activities and processes to provide support to the US Medical
Affairs Patient Safety business unit that are both routine and very specific depending on the query. This role impacts the reputation of the function it serves as the initial point of contact for many customers.
Regulatory preparation & submission experience of single AE cases to meet FDA expedited reporting requirements
o IND Cross Reporting submission experience
o Investigator Safety Letter submission experience
AE Reconciliation experience (vendors, license partners, etc.)