Scientist, ICSR Management

About the Company

At Daiichi Sankyo, we are united by a single purpose: to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society," we are shaping a healthier, more hopeful future for patients, their families, and society.

About the Role

This position is responsible for evaluating and submitting adverse event reports in accordance with DS policy and regulatory authority requirements. This role supports configuration requests and User Acceptance Testing (UAT). The position primarily interacts within CSPV, including collaboration with other DSPD sites and providing ICSR notifications to partners. The role is expected to handle ICSR issues in accordance with SOPs, SOIs, and experience, escalating 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 them 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 the development of process guides to ensure consistency and compliance in case processing and adherence to regulatory guidelines. Supports the review of updates to 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.

Requirements

• Bachelor's Degree in nursing, pharmacy, or a healthcare-related field preferred, or in lieu of education, 4+ years of PV (Pharmacovigilance) experience is required.
• 1 or more years of PV experience and knowledge of FDA regulations required.

Pay

Salary Range: USD $100,960.00 – USD $151,440.00