Drug Safety Scientist
Reporting to Executive Director, Safety Evaluation and Risk Management and will have has the primary responsibility for the support of signal management activities for medical products under development or in postmarketing.
Safety Scientist conducts aggregate analysis for signal detection, signal analysis, signal evaluation and risk management.
- Support safety surveillance activities and contribute to safety analysis and risk management planning for designated products
- Track, detect and evaluate safety signals in consultation with the SERM leads
- Prepare safety evaluation reports for safety signals or other issues (e.g., product quality)
- Support the preparation and maintenance of safety sections of Company Core Data Sheet, Investigator’s Brochure and ICF for assigned products
- Prepare and review periodic aggregate safety reports (PADER, PSUR/PBRER, DSUR, IND Annual Report, 6-month line-listings)
- Support SERM 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, as needed
- Support the SERM Lead in responding to safety requests for assigned product(s) from regulatory authorities, affiliates and other internal functions
- Represent Drug Safety in cross-functional team meetings for designated product(s)
- Attend weekly internal safety meetings (Safety Surveillance & Epidemiology and Global Safety Team) 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
- Medical/Clinical degree including MD, PharmD, MPH/PhD, or BS RN degree
- Minimum 1-2 years of industry experience in drug safety and/or risk management is desired for the Safety Scientist role. Higher level such as Sr Safety Scientist/Manager will be considered for more experienced candidates
- Oncology safety science experience preferred
- Experience as a safety epidemiologist or appropriate epidemiology qualification will be desirable
- Good Knowledge of US and EU drug safety and pharmacovigilance regulatory guidance
- Good knowledge of drug safety/pharmacovigilance practices and tools (e.g., ARGUS database, TIBCO Spotfire, MedDRA, Medidata)
- Good medical and scientific judgement, attention to detail and excellent interpersonal skills, including 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 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.