Associate/Medical Director, Medical Review

Location
Bothell, WA, United States
Posted
Aug 09, 2019
Ref
o79gafwq
Required Education
Doctorate/PHD/MD
Position Type
Full time

Summary:

The Medical Reviewer, Drug Safety is responsible for guiding, implementing and executing the processes that support medical content of clinical trial and/or post-marketing adverse event reports; ensures that consistent, timely, and focused medical review and assessments for safety cases are conducted according to regulatory and departmental timelines at the individual level. This position facilitates timely discussion and communication of information related to safety signal evaluation and serves as a medical resource for the Safety Evaluation and Risk Management team as required.

Responsibilities:

  • Serve as a point of contact between Drug Safety Operations and the Safety Evaluation and Risk Evaluation (SERM) team regarding medical content and regulatory reporting for program-specific ICSRs
  • Communicate with SERM Program and Risk Leads regarding cases of special interest or SUSAR reports from clinical trials and provide medical insights on case information
  • Provide medical review expertise and guidance on interdepartmental and/or cross-functional initiatives including, process improvement standards development, SOP/MAN creation, and metrics with regards to medical review and case processing
  • Support the development and review of expected term lists to facilitate expectedness assessments
  • Perform individual safety case medical assessments of causality, expectedness and seriousness of reported clinical trial and post-marketing safety reports in alignment with corporate SOPs
  • Contribute to the resolution of issues from cases of high complexity through medical expertise and team interactions
  • Ensure the medical accuracy of the narrative and medical coding within each safety report and provide sponsor comment on individual safety reports where required
  • Conduct evaluation of other relevant safety information (e.g. from non-clinical studies and product quality complaints) as required
  • Approve all potential expedited reports to global health authorities from a medical perspective as assigned
  • Identify appropriate medical questions/queries to support appropriate safety case follow up per corporate SOPs
  • Create search criteria and prepare Analysis of Similar Events (AOSE)
  • Contribute to solving reconciliation coding issues/discrepancies
  • Support training to Drug Safety employees on ICSR medical review activities and processes
  • Manage internal Medical Review personnel including goal setting and providing Manager Performance Evaluation Assessments
  • Mentor medical review staff
  • Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness
  • Serve as point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
  • Perform quality review of vendor medical review task against Drug Safety process and procedures and recommend corrective actions
  • Perform other drug safety operations tasks as determined by manager


Qualifications:

 

  • At least 7-10 years relevant pharmaceutical industry experience/expertise, with significant previous experience in pharmacovigilance in a medical or operational position
  • Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure
  • Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
  • Proven ability to strategically apply principles of clinical assessment of adverse events in the pharmaceutical industry
  • Robust knowledge of MedDRA dictionary with relevance to adverse event coding
  • Strong clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Experience leading teams and managing staff
  • Strong analytical, assessment and problem-solving skills
  • Demonstrated ability to read, analyze and interpret clinical data and information
  • Excellent interpersonal skills and professionalism


Education:

 

 

  • MD (preferred)


As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.