Safety Scientist is responsible for carrying out pharmacovigilance and drug safety activities for assigned product(s). This position supports Safety Evaluation and Risk Management (SERM) activities for signal detection, analysis and its presentation. Safety Scientist also supports the preparation of periodic safety reports including PBRER, DSUR, RMP to the regulators in a timely manner.
Reporting to the Head of Safety Surveillance and Epidemiology, the safety scientist will support proactive safety surveillance and signal detection activities
Track, detect and evaluate safety signals in consultation with the safety surveillance and risk management leads
Support the preparation and maintenance of informed consent and risk profile of assigned products
Prepare safety evaluation reports in consultation with Safety Surveillance and Risk Management leads
Contribute in the preparation of periodic aggregate safety reports including PADER, PSUR/PBRER, DSUR, IND Annual Report, and RMP
Represent drug safety in Study Team Meetings and/or Clinical Sub Team Meetings.
Attend weekly internal safety surveillance meetings and cross-functional team meetings to relay safety concerns and communicate to SERM regarding issues raised in the clinical study meetings
Medical/Pharmacy degree including MD, PharmD, Master's Public Health, or BS RN degree
3 or more years industry experience in pharmacovigilance and drug safety
Oncology safety science experience preferred
Good knowledge of drug safety/pharmacovigilance guidances, databases and tools (e.g., ARGUS database, Spotfire, MedDRA, Medidata)
Good medical and scientific judgment, attention to detail and excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
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.