Associate Medical Director, Safety Evaluation & Risk Management (SERM)
This position will be responsible for 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; Clinical Affairs, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal.
- 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
- Participate in protocol development to ensure alignment with risk management plans and effective collection of safety data
- Represent Drug Safety in data standards committee
- Participate in the Signal Management System with regular review of safety data for assigned products for identification and evaluation of new safety signals
- Responsible for safety data review - to include individual case review and aggregate safety assessment and analysis using safety data from clinical trials or post-marketing sources
- Perform/provide oversight for 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 clinical practice experience. Oncology safety science experience preferred
- Training in clinical research experience desired
- Clinical data collection, assessment and analysis
- Excellent interpersonal skills & 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.