Medical Director, Safety Evaluation & Risk Management (SERM) - Bothell, WA | Biospace
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Medical Director, Safety Evaluation & Risk Management (SERM)

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
7/24/2017
Position Type:
Full time
Job Code:
2026
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description

Summary:

The Medical Director/ Sr. Medical Director SERM will be responsible for strategic medical leadership for global pharmacovigilance and risk management activities for assigned Seattle Genetics, Inc. investigational and marketed products.

This individual will serve as a member of the Drug Safety leadership team 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, Translational & Experimental Medicine and Legal.

Responsibilities:

  • Provide oversight for members of the Safety Evaluation and Risk Management (SERM) group in Drug Safety
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  • Represent Drug Safety in Clinical Sub Team for assigned investigational products providing expert medical guidance regarding safety matters and issues
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  • Lead Safety Management Team for assigned pre-marketing and/or post-marketing product(s) and all associated risk management activities
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  • Participate in the Signal Management System with regular review of safety data for assigned products for identification and evaluation of new safety signals
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  • Perform/provide oversight for medical review of individual safety reports from clinical trials or post-marketing sources
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  • Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR)
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  • Participate in protocol development to ensure alignment with risk management plans
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  • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, SMC/IDMC Charters
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  • Contribute to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports
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  • Facilitate 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
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  • Participate in continuous improvement activities including systems design, performance measurement and quality management
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  • Provide guidance and mentorship to staff on pharmacovigilance and risk management best practices and safety science
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  • Provide input to Pharmacovigilance agreements and interactions
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  • Participate in alliance safety teams with external partner (s)
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Requirements

Qualifications:

  • MD (board certified or ex-US equivalent)

Experience and Background:

  • Minimum of 3 years (Director) or 5 years (Sr Dir) in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management
  • Oncology safety science experience preferred
  • 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
  • Excellent written and spoken English
  • Prior experience with business partners a plus

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.