*This position is onsite in Ridgefield, CT & remote*
Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.
Duties & Responsibilities:
- Daily submissions of follow-up queries to appropriate adverse event reporters and QC of follow-up queries
- Deliverables: GCM associates are responsible for sending follow-up queries to US domestic reporters of adverse event reports. These queries are usually sent to provide further information, updates, or requests related to previously submitted adverse event reports. Additionally, GCM associates review queries initiated in the safety database to ensure that the purpose of the follow-up is communicated in a professional manner.
- Responsibilities The GCM team is responsible for initiating follow-up query requests, but the submission of these requests is supported by the Global Case Management Associate in PSPV.
- Daily review of correspondence module in the safety database to monitor responses to follow-up queries received from adverse event reporters
- Deliverables: On a daily basis, GCM associates review the correspondence module in the safety database to monitor responses received from adverse event reporters regarding follow-up queries. After confirming that responses to follow-up requests have been received, the queries are closed in the global safety database.
- Responsibilities Monitoring these responses to queries daily and taking appropriate actions are tasks performed independently by the Global Case Management Associate.
- Conducting and supporting various reconciliation-related tasks including reconciliation of Investigator Initiate Studies, License Partner s information and Product Complaints
- Deliverables: Support GCM associates perform reconciliation tasks by comparing and analyzing the data from various sources, such as Investigator Initiated Studies, License Partner s information and Product Complaints, documenting the results, discrepancies and taking appropriate actions for each data source.
- Responsibilities PSPV teams and/or License Partners provide reconciliation reports to perform the reconciliation of these sources. The global Case Management Associate in PSPV supports the reconciliation process for these sources with GCM s oversight.
- Support IND submission-related activities.
- Deliverables: Perform activities supporting the fulfillment of PSPV s expedited reporting obligations to US FDA.
- Responsibilities Ensure IND safety reports are uploaded in the correct format for Regulatory Affairs (RA). Ensure submissions performed by RA are properly documented in the safety system. This task is performed independently by the Global Case Management Associate in PSPV.
- Veeva review.
- Deliverables: Daily review of Veeva reports for potential AEs.
- Responsibilities Independently review comments in Veeva for potential AE reports. Act on any potential report in a timely manner or seek clarification when needed from the source of the comment.
- Support ad hoc departmental projects and activities as they relate to the organizational components of ICSR processing.
- Deliverables: GCM associates support ad hoc departmental projects and activities related to the organizational components of ICSR processing.
Experience and Skills Requirements:
- 4 Year college degree
- 2+ years of case report processing and auditing experience
- Project management and administrative skills
- Medical and clinical terminology
- Strong communication skills
- Proficiency in computer skills, with direct working experience in multiple electronic platforms
- MS Office skills
Job Type:Full-time
Hybrid position
Ridgefield, CT