ICSR & PV Submissions Specialist

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 101,000 - 151,000; Full time

Job summary

Daiichi Sankyo is seeking a PV professional in the United States to evaluate and submit adverse event reports in accordance with DS policy and regulatory requirements. The role supports configuration requests, User Acceptance Testing (UAT), and interactions with CSPV and partner sites.

The position requires handling ICSR issues per SOPs and SOIs, escalating complex matters to Level III, and contributing to process guides, SOP updates, and training materials related to AE intake and submissions.

Qualifications

• Bachelor's degree in nursing, pharmacy, or healthcare field preferred; 4+ years PV experience acceptable in lieu.
• 1+ year PV experience and knowledge of FDA regulations required.

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.

Education

Bachelor's degree in nursing, pharmacy, or healthcare related field

Job description

Daiichi Sankyo is seeking a PV professional in the United States to evaluate and submit adverse event reports in accordance with DS policy and regulatory requirements. The role supports configuration requests, User Acceptance Testing (UAT), and interactions with CSPV and partner sites.

The position requires handling ICSR issues per SOPs and SOIs, escalating complex matters to Level III, and contributing to process guides, SOP updates, and training materials related to AE intake and submissions.