Seagen

Associate Director SERM

Technical Operations & Process Sciences - Bothell, United States

Summary

Description

This position will be responsible for signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned Seagen, Inc. investigational and/or marketed products. The successful candidate will serve as a member of the Global Safety Risk Management 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.

Requirements or Responsibilities:

• Represent Global Safety in Clinical Sub Team and Study teams for assigned investigational products providing expert medical guidance regarding safety issues
• Responsible for signal validation, developing strategy on signal evaluation, interpreting safety results, presenting signal assessment and proposed actions to multidisciplinary global safety teams and safety governance
• Develop search strategies for AESI, and signal detection plan
• Contribute to submission activities involving safety related topics, safety data presentation strategies, safety data review, safety document review
• Contribute to label development
• Draft responses to safety queries from health authorities or IRBs
• Review and provide analysis for the support of key study-related documents, e.g., IB, Risk Profiles, ICF, SMC/IDMC
• Participate in protocol development to ensure alignment with risk management plans and effective collection of safety data
• 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
• Represent Global Safety in data standards committee
• Contribute to department initiatives/projects
• Supports and contributes to activities for a product registrational filing

Qualifications:

• 7 years of relevant experience in Global Safety Risk Management, Clinical Safety, Pharmacovigilance or Risk Management preferred
• Clinical research experience with exposure to clinical data collection, assessment, and analysis desired
• Oncology safety science experience preferred
• Prior experience with business partners a plus
• Knowledge of ICH, US & EU regulations, and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required)
• Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
• Proficiency in use of Excel and Microsoft Office
• Excellent written and spoken English

Education:

• Medical/clinical degree (board certified/board eligible or ex-US equivalent), PhD in a relevant area, PharmD, MPH/MSN, or BSN degree

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.

The hiring pay range for this position is $203,000 - $263,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/10/2023