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System One Services Manager, Safety Evaluation & Risk Management in Bothell, Washington

Manager, Safety Evaluation & Risk ManagementBothell, Washington (/all-jobs?geoId=c8513792-de5a-11ea-b61e-42010a8a0ff4)

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Category:Scientific & Clinical

Job ID:184714

Date Posted:01/12/2021

Job Title: Manager, Safety Evaluation & Risk Management

Contract Length: 6 mos

Number of Openings: 1

Job Description:

This position will be responsible for supporting the SERM Program Lead or assigned Risk lead in the signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned COMPANY, Inc. investigational and/or marketed products. The successful candidate will serve as a member of the Patient Safety department and function in a company matrix team environment interacting with several key internal & external (i.e. partners) stakeholder groups including; Development-Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal.


May represent Drug Safety in Clinical Sub Team and Study teams for assigned investigational products providing expert medical guidance regarding safety issues

• Review and provide analysis for the support of key study-related documents, e.g. IB, ICF, SMC/IDMC with guidance from SERM Risk lead or Program lead

• Provide assistance in protocol development to ensure alignment with the current development product adverse event profile, risk management plans and effective collection of safety data

• Support other program-level activities, such as pre-BLA preparation of documents, safety deliverables (SCS, ADR tables, etc) as assigned, and program-specific data quality assessments

• Support inspections and audits

• Participate in the Signal Management System with supervision from the SERM Risk lead or Program Lead, with regular review of safety data for assigned products for identification and evaluation of new safety signals

• Help safety data review to include individual case review and aggregate safety assessment and analysis using safety data from clinical trials or post-marketing sources with guidance from SERM Risk lead or Program lead

• May aid in medical review of individual safety reports from clinical trials or post-marketing sources with guidance from SERM Risk lead or Program lead

• Contribute to preparation and review of periodic reports (PADER; DSUR; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report)

• Participate in production and maintenance of risk management plans and safety communication to regulatory agencies or third parties (marketing applications, company core safety information, regulatory safety queries, etc.) with guidance from SERM Risk lead or Program lead

• May represent SERM in data standards committee

• May mentor other Patient Safety Team members, or new hires in SERM


• Pharm D, Ph.D, MD (board certified/board eligible or ex-US equivalent)

• Proficiency in use of Excel, Microsoft Office and PowerPoint

• Some working knowledge of Safety-relevant software (e.g. Spotfire, J-Review)

• Some working knowledge of Safety related databases (e.g. Argus)

• Minimum 2 years of relevant safety pharmacovigilance training in a pharmaceutical company. Oncology safety science experience preferred

• Clinical research experience desired

• Exposure to clinical data collection, assessment and analysis

• Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally

• Excellent written and spoken English

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