Senior Safety Surveillance Scientist
The Senior Safety Surveillance Scientist will report to the Safety Surveillance Manager or GSRM Program Lead. The primary responsibility will be to support signal management activities for medical products under development and in postmarketing. The Safety Surveillance Scientist, Senior also supports the Safety Surveillance function within Safety Evaluation in aggregate analysis for signal detection, signal analysis, signal evaluation.
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
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 judgment, attention to detail, and excellent interpersonal skills, including the 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 Seattle Genetics, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.