Seagen

Safety Scientist SERM

Development - Bothell, Washington

Description

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 Safety Scientist, SERM will report to the Global Safety Program Lead (GSPL) in Global Safety Risk Management (GSRM). The primary responsibility includes the support of signal management activities for medical products in clinical trials and in post marketing settings, encompassing signal detection, signal analysis, signal evaluation, and risk management. The successful candidate will serve as a member of the GSRM department and function in a company matrix team environment interacting with several key internal stakeholder groups including Global Safety Operations, Development-Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal.

Principal Responsibilities:

• Supervised by the GSRM Risk Management Lead (RML) or Global Safety Program Lead (GSPL), the Safety Scientist will conduct daily, weekly, and monthly review of clinical trials and/or post-marketing safety data for assigned products.
• Under the guidance of the RML or GSPL, the Safety Scientist will assist in the detection, analysis, and evaluation of safety signals.
• Collaborate with members of Global Safety Operations including Case Management, Medical Review, Safety Systems, and Safety Compliance to ensure timely delivery of product level deliverables and timelines.
• Under the supervision of the RML, prepare safety evaluation reports for safety signals or other issues (e.g., Emerging safety issue, clinical trial SUSAR, product quality, medical affairs).
• Support the supervised 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 and maintain Risk Profiles for development and comparative products under the direction of the RML and GSPL.
• Prepare safety content and review periodic aggregate safety reports (PADER, PSUR/PBRER, DSUR, IND Annual Report, 6-month line-listings).
• Support RML and GSPL 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 RML in responding to safety requests for assigned product(s) from regulatory authorities, affiliates, and other internal functions (e.g., Clinical Trial Managers questions from Ethic Committees/ IRB questions).
• Represent SERM 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, as assigned.
• Prepare and communicate findings of surveillance activities and safety assessments to internal safety stakeholders.
• Contribute to regular literature review, including assessment, interpretation, and preparation of results for inclusion into relevant safety documents, e.g., Periodic Reports.

Qualifications:

• 1-3 years relevant experience in pharmacovigilance or clinical trials research experience preferred.
• Oncology safety science experience preferred.
• Working knowledge of pharmacovigilance regulatory guidance in US, Canada, Europe, and other global regions.
• Working knowledge of pharmacovigilance practices and tools (e.g., ARGUS database, Spotfire, MedDRA, Signal detection tracking tool).
• Proven medical and scientific judgement, attention to detail and excellent interpersonal skills, including ability to work effectively cross culturally and cross functional.
• Ability to manage assigned projects independently or under supervision of GSL or delegated safety staff.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/29/2022