This position will be responsible for supporting the SERM lead, or Program Head in the signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned Seattle Genetics, Inc. investigational and/or marketed products. The successful candidate will serve as a member of the Drug Safety 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.
May represent Drug Safety 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
Provide SERM lead support in protocol development to ensure alignment with the current development product adverse event profiler, risk management plans and effective collection of safety data
May represent SERM in data standards committee
Participate in the Signal Management System with supervision from the SERM lead or Program Head, with regular review of safety data for assigned products for identification and evaluation of new safety signals
Support safety data review - to include 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 and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties
MD (board certified/board eligible or ex-US equivalent)
Proficiency in use of Excel and Microsoft Office
Minimum 3 years of relevant safety pharmacovigilance training in a pharmaceutical company. Oncology safety science experience preferred
Clinical research experience desired
Exposure to clinical data collection, assessment and analysis
Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
Excellent written and spoken English
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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.seattlegenetics.com.
Seattle Genetics 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.