Seagen

Senior Safety Scientist SERM

Development - Bothell, United States

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 Senior Safety Scientist, SERM will report to the Global Safety Program Lead (GSPL) in Global Safety Risk Management (GSRM). The primary responsibility will be to support signal management activities for medical products under development and in post marketing, including 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. The position requires a demonstrated ability to plan, prioritize, and collaborate to accomplish time sensitive deliverables, be resourceful and able to problem-solve and take initiative to ensure optimal results and meet project timelines.

Principal Responsibilities:

• With supervision by the Risk Management Lead (RML) or GSPL, conduct daily, weekly, and monthly review of clinical trials and/or post-marketing safety data for assigned products. Identify and evaluate new safety signals, performing individual case review and aggregate safety assessment as appropriate.
• Conduct regular reviews of individual safety reports from clinical trials or post-marketing sources.
• Plan, execute and interpret results for comprehensive signal evaluation analysis for designated products in consultation with the RML and GPSL for the molecule.
• Prepare and communicate findings from surveillance activities, safety assessments and/or other sources of safety data (e.g., Emerging safety issues, clinical trial SUSAR, product quality, medical affairs).
• Support the RML in responding to safety requests from regulatory authorities, affiliates, and internal functions (e.g., Clinical Trial Managers, Ethic Committees/ IRBs) for assigned product(s)
• Contribute to safety content for protocols in development and protocol amendments as well as to Clinical Study Reports as assigned by RML or GSPL.
• Review and provide analysis to support key study-related documents, e.g., IB, ICF, SMC/IDMC; develop Risk Profiles for development and comparative products as needed.
• May represent SERM in Clinical Sub Team and Study teams for assigned investigational products and provide guidance regarding safety issues.
• Support the preparation, maintenance, and review of safety sections of Reference Safety Information (Company Core Data Sheet, Investigator’s Brochure, Clinical Summary of Safety, Clinical Study Reports).
• Contribute to literature search strategy for product(s) and conduct regular literature review, including assessment, interpretation, and preparation of results for inclusion into relevant safety documents, e.g., Periodic Reports.
• 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 updates of RMP, Risk Minimization strategies (e.g., REMS), and benefit risk analysis.
• Manages the preparation and logistics for weekly SERM safety meetings, cross-functional Global Safety Team and co-license partner joint meetings discussing safety concerns and analytic plans. May present signal analysis strategy and results at these meetings.
• May represent SERM in GSRM and perform other PV tasks including process improvement work groups and initiatives, and contribute/lead to special projects, as assigned.

Qualifications:

• 4 years relevant industry experience, 2 years in Pharmacovigilance & Risk Management preferred.
• Working knowledge of pharmacovigilance regulatory guidance in US, Canada, Europe, and other regions.
• Working knowledge of pharmacovigilance practices and tools (e.g., ARGUS database, Spotfire, MedDRA, WHO-Drug and 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 functionally.
• Demonstrated ability to manage projects independently.
• Ability to support multiple products, potentially in different phases of development, in parallel.

• 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/13/2022