Catalyst Pharmaceuticals is a science-based pharmaceutical company dedicated to meeting the needs of its customers with rare diseases.  Catalyst is a growing, profitable, Fortune's best to work for company located in Coral Gables, Florida. 

This position is responsible for executing U.S. Adverse Event and pharmacovigilance activities as required by FDA regulations. 

 Duties and responsibilities

·         Reviewing and approving serious and non-serious serious adverse events in conjunction with our PV vendor

·         Ensuring the timely submission of US Adverse Events and notification of our marketing partners through our PV vendor

·         Ensure complete and quality submissions are performed by the PV vendor

·         Reconcile adverse events with clinical database for IND studies and review DSUR for completeness

·         Performing reconciliation with business partners and vendor for AE report exchanges

·         Ensure product complaints are separated from AE reports and sent to QA for processing

·         Review of signal detection of products from PV vendor

·         Other PV responsibilities as assigned but not limited to the above

 

Qualifications

·         Degree in Nursing - RN

·         Minimum of 3 years of PV experience in pharmaceuticals, mainly reviewing Adverse Event and Periodic Reports

·         Familiar with FDA regulations and ICH guidance

·         Excellent verbal, written, and organizational skills.

·         Strong knowledge of MS Office (Word, Excel, PowerPoint)

·         Strong attention to detail and closed loop thinking

·         Must possess the ability to work effectively and collaboratively in a growing company environment. 

·         Ability to work under minimal supervision and often independently