Job Summary

This position is responsible for evaluating, and submitting adverse event reports in accordance to DS policy and regulatory authority requirements. This position supports configuration requests and User Acceptance Testing (UAT) . This level interacts within CSPV for the majority of the time, which includes interactions with other DSPD sites and giving ICSR notifications to partners. This position is expected to handle ICSR issues in accordance with SOPs, SOIs, and experience and escalate more complex problems to Level III.

Responsibilities

ICSR Processing: Support intake and adverse event processing activities including data entry (i.e. PQC results). Support follow-up phone calls to reporters. Initiate SAE recon activities in collaboration with CRO management and cross functional groups (i.e data management). Support CAPA investigations related to ICSR adverse event (AE) intake and regulatory submissions activities. ICSR Submission: Includes the daily review and evaluation of DSI bulk reporting.. Monitors daily ICSR pending and negative acknowledgements. Reviews queries and addresses through to resolution. Initiates global system configuration requests, product approvals, and PVAs. Conducts User Acceptance Testing (UAT) for change requests (CRs) to validate CRs and ensure compliance. Case Processing Policies and Procedures: Participates in development of process guides which are used to ensure consistency and compliance in case processing and adherence to regulatory guidelines. Support review for updates of global standard operating procedures (SOPs), training materials, and processes related to adverse event (AE) intake and submission activities. Supports the review of Pharmacovigilance Regulatory Intelligence (PVRI) to assess potential process and compliance impacts.

Qualifications