Associate Medical Director, Safety Evaluation & Risk Management (SERM) in Bothell, WA

$80K - $100K(Ladders Estimates)

Seattle Genetics   •  

Bothell, WA 98011

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 46 days ago

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

Responsibilities:

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

Participate in protocol development to ensure alignment with risk management plans and effective collection of safety data

Represent Drug Safety in data standards committee

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

Requirements:

MD (board certified/board eligible or ex-US equivalent)

Proficiency in use of Excel and Microsoft Office

Minimum 3 years of clinical practice experience. Oncology safety science experience preferred

Training in clinical research experience desired

Clinical data collection, assessment and analysis

Excellent interpersonal skills & ability to work effectively cross culturally and cross functionally

Excellent written and spoken English.


Valid Through: 2019-10-29