Job details

Associate, Safety Alert Reporting

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Job Summary

The Associate, Safety Alert Reporting will perform all activities related to the distribution of Individual Case Safety Reports (ICSRs). The Associate must possess strong computer skills for database management, data entry, and troubleshooting. The ideal candidate has problem solving and critical thinking skills, meticulous attention to detail, proofreading/QC, and time management skills, which are essential for success in this role. This two-person, time sensitive, process requires a candidate that is reliable, dependable, and dedicated to ensure deadlines are met.

Essential Functions

Creation, or review, of all ICSR documents including, but not limited to: SUSARs, IND Safety Alerts, Six Monthly Line Listings, DSURs etc. 50%
Maintenance of safety alert reporting database including, but not limited to: archiving, troubleshooting, reconciliations. 10%
Develop an understanding of country specific, Regulatory reporting requirements for 50+ countries worldwide. 5%
Interact/collaborate with interdisciplinary groups such as Safety, Study Teams, CROs, and IT in order to resolve distribution issues. 5%
Identify issues with the distribution of safety alert reports in order to provide support to the study teams for all inspection readiness activities. 15%
Perform daily document management activities such as: proofreading, scanning, electronic and hard copy filing, uploading and importing data and/or documents into relevant databases. 10%
Participate in, and support, other projects within Global Regulatory Clinical Services. 5%

Requirements

Bachelor's Degree required
1-3years of Pharmaceutical experience
Must be able to analyze issues in order to discover the root cause
Strong computer skills, particularly experience with database management, data entry, and troubleshooting
Strong follow through skills are necessary to ensure submissions reach their final destination in a timely manner
Knowledge of safety report submission activities is a plus
Strong desire to learn and the ability to quickly grasp multiple skills simultaneously
Regulatory experience is a plus.
Strong proofreading, editing, and reviewing skills are required
Must be detail oriented, highly organized, and quality driven
Possess a strong work ethic and be able to work both as part of a team and independently
Prior experience dealing with sensitive, or confidential, documentation
Experience contributing to guidance documents (SOPs/SWPs/User Manuals etc.)
Strong written, and verbal, communication skills

#LI-MG1

IND123

Eisai Salary Transparency Language:

The base salary range for the Associate, Safety Alert Reporting is from :58,600-76,900

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit

https://us.eisai.com/careers-at-eisai/benefits

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work

E-Verify Participation

Eisai Glassdoor Company Review

3.5