Scientist, ICSR Management

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

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.

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

Education Qualifications

Bachelor's Degree in nursing, pharmacy, or healthcare related field preferred or In lieu of education 4+ years of PV experience is required.

Experience Qualifications

1 or more years of PV experience and knowledge of FDA regulations required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$100,960.00 - USD$151,440.00