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Principal Safety Scientist SERM

Employer
Seagen
Location
Bothell, Washington State
Salary
Competitive pay, 401k, Medical/Dental/Vision benefits
Closing date
Jul 30, 2022
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Job Details

Summary: 

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. 

Principal Responsibilities: 

  • 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 

Qualifications: 

  • 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 

Education: 

  • 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. 

Company

Seagen is a global biotechnology company that develops and commercializes transformative cancer therapies. We’re driven by a singular mission—to make a difference for people impacted by cancer.

As an industry leader in antibody–drug conjugate (ADC) technology, we pioneered the science of harnessing antibodies designed to deliver cell-killing agents to cancer cells. Three of our four approved medicines are built on this technology.

We also focus our research efforts on novel targeted small molecule therapies. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents.

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