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!

Summary:

The Sr. Safety Scientist will report to the Safety Surveillance Manager or GSRM Program Lead. The primary responsibility will be support of signal management activities for medical products under development, and in post marketing. The Sr. Safety Scientist also supports the Safety Surveillance function within Safety Evaluation in aggregate analysis for signal detection, signal analysis, signal evaluation.

Responsibilities:

• Daily, weekly, monthly safety surveillance activities
• Safety analysis planning for designated products (early and late stage, marketed products)
• Track, detect and evaluate safety signals in consultation with the SERM Risk and Program Leads
• Prepare safety evaluation reports for safety signals or other issues (e.g., Emerging safety issue, clinical trial SUSAR, product quality, medical affairs)
• Support the preparation, maintenance, and review of safety sections of Reference Safety Information (Company Core Data Sheet, Investigator’s Brochure, RMP, Clinical Summary of Safety, Clinical Study Reports)
• Develop Risk Profiles for development and comparative products
• Prepare and review periodic aggregate safety reports (PADER, PSUR/PBRER, DSUR, IND Annual Report, 6-month line-listings)
• Support SERM Risk and Program Lead in the development and/or execution of RMP, REMS, and benefit risk analysis
• Contribute to safety content in the review of clinical protocols and study reports
• Support the SERM Lead in responding to safety requests for assigned product(s) from regulatory authorities, affiliates and other internal functions (eg Clinical Trial Managers questions from Ethic Committees/ IRB questions)
• Represent Drug Safety in cross-functional team meetings for designated product(s)
• Attend weekly internal safety meetings and cross-functional meetings to discuss safety concerns and analytic plan
• Present signal analysis strategy and results to joint safety meetings with co-license partners
• Contribute to Special Projects
• Direct special projects
• Prepare and communicate findings of surveillance activities and safety assessments

Qualifications:

• Medical/Clinical degree including MD, PharmD, MPH/PhD, or BS RN degree
• Minimum of 3-4 years of industry experience or clinical trials research experience in Safety Scientist role
• Oncology safety science experience preferred
• Experience as a safety epidemiologist or appropriate epidemiology qualification will be desirable
• Good Knowledge of US, Canada, Europe and other global regions (eg Asia) drug safety and harmacovigilance regulatory guidance
• Good knowledge of drug safety/pharmacovigilance practices and tools (e.g., ARGUS database, TIBCO Spotfire, MedDRA, Medidata, Signal detection tracking tool)
• Good medical and scientific judgement, attention to detail and excellent interpersonal skills, including ability to work effectively cross culturally and cross functional
• Prefer experience in managing direct reports and projects, independently

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.

The hiring pay range for this position is $130,000 to $168,300 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.