Seagen
Drug Safety Operations Coordinator
Drug Safety & Pharmacovigilance - Bothell, Washington
Description
Summary
The Drug Safety Operations Coordinator is responsible for the facilitation of the workflow of serious adverse event (SAE) reports for investigational products and adverse event (AE) reports for marketed products. This position manages the intake of all safety information received by Drug Safety Operations and tracks timelines to ensure compliance of safety reporting to business partners and Health Authorities. In addition, this position collaborates with various teams in Drug Safety Operations to develop and enhance Drug Safety processes and procedures.
Responsibilities:
- Manage the workflow of all safety information received into the department to facilitate routing, review, approval, and timely case finalization, submission, and archiving
- Intake and documentation of receipt of safety reports, follow-up information, and source documents
- Send team notifications of receipt of safety information in accordance with Safety Management Plan timelines
- Data entry of basic fields into Drug Safety Database
- Preliminary coding of all adverse event terms
- Assess reports for follow-up reporting requirements
- Oversee the progression of cases through departmental workflow and ensure timely completion of submissions and case closure procedures
- Manage timelines for reporting Individual Case Safety Reports (ICSR) to pertinent regulatory agencies to ensure that global regulatory reporting requirements are met
- Implement and manage the filing (electronic and hardcopy) of all documents associated with the collection, preparation, and reporting of SAEs for all in house studies and/or partnered studies and/or CRO managed studies
- Collaborate to maintain, develop and/or enhance departmental work procedures
- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
- Perform other duties related to the position as required
Requirements:
- Strong communication (verbal and written) skills
- Demonstrated knowledge and understanding of domestic and international regulatory safety reporting requirements
- 2+ years of comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs
- Excellent organizational skills and attention to detail
- Excellent interpersonal skills, including the ability to work effectively cross-culturally and cross-functionally
Education
- Junior-level college degree or equivalent training
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
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Seagen
Seagen is an Equal Opportunity Employer
Submitted: 03/26/2021
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