Medical Director, Safety Evaluation & Risk Management in Bothell, WA

$100K - $150K(Ladders Estimates)

Seattle Genetics   •  

Bothell, WA 98011

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 41 days ago

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

Represent Drug Safety in Clinical Sub Team for assigned investigational products providing expert medical guidance regarding safety matters and issues

Lead Safety Management Team for assigned pre-marketing and/or post-marketing product(s) and all associated risk management activities

Participate in the Signal Management System with regular review of safety data for assigned products for identification and evaluation of new safety signals

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 protocol development to ensure alignment with risk management plans

Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, SMC/IDMC Charters

Contribute to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports

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

Participate in continuous improvement activities including systems design, performance measurement and quality management

Provide guidance and mentorship to staff on pharmacovigilance and risk management best practices and safety science

Provide input to Pharmacovigilance agreements and interactions

Participate in alliance safety teams with external partner(s)

Requirements:

MD (board certified or ex-US equivalent)

Minimum of 3 years (Director) experience 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.


Valid Through: 2019-10-29