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.

Principal 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

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

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