Principal Safety Scientist SERM
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
This position will be responsible for supporting the Global Safety Program Lead (GSPL) in the signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned Seagen, Inc. investigational and/or marketed products. The successful candidate will serve as a member of the Global Safety Risk Management department and function in a company matrix team environment interacting with several key internal stakeholder groups including Development-Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal. The position requires demonstrated ability to proactively plan, prioritize, align, and collaborate to achieve results while managing complex and time sensitive deliverables and multiple stakeholders.
- May represent Global Safety Risk Management in Clinical Sub Team and Study teams for assigned investigational products providing expert medical guidance regarding safety issues
- Review and provide analysis for the support of key study-related documents, e.g., IB, ICF, SMC/IDMC
- Support the GSPL or Risk Management Lead (RML) in proactive safety sections proposals for protocol development and amendments that ensure alignment with the current product adverse event profile, risk management plans and effective collection of safety data
- May represent SERM in data standards committee; may lead internal GSRM quality/process improvement initiatives as assigned.
- Independently conduct regular review of safety data for assigned products for identification and evaluation of new safety signals with oversight from the RML or GSPL, to inclusive of individual case review and aggregate safety assessment and analysis using safety data from clinical trials or post-marketing sources
- May support medical review of individual safety reports from clinical trials or post-marketing sources
- Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR)
- Participate in production and maintenance of risk management plans, development of additional risk minimization measures, and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties
- 5 years relevant industry experience, 3 years in Pharmacovigilance & Risk Management preferred
- Clinical research experience with exposure to clinical data collection, assessment, and analysis desired
- Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
- Excellent written and spoken English
- Proficiency in use of Excel and Microsoft Office
- Medical/clinical degree (board certified/board eligible or ex-US equivalent), PhD in a relevant area, PharmD, MPH/MSN, or BSN degree
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.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.