Associate Director, ICSR-Medical Evaluation Cambridge, MA
Department: Research & Development
Company Description The Associate Director, Medical Evaluation
is responsible for the medical content and assessment of
post-marketing and/or clinical trial adverse event reports, and
serving as a medical resource for the GSRS,GCM, AR & SS team,GSRS
department, and other cross-functional teams as needed. This
position ensures that consistent, timely, and focused medical
review for safety cases is conducted according to regulatory and
departmental timelines at the individual level, and facilitates
timely discussion and communication of information related to
safety signal evaluation.
Job Description Completes assessment and medical review of
post-marketing and/or clinical trial adverse event reports within
regulatory and departmental timelines o Ensures adequacy of
recording,summarization, and handling of adverse events for
marketed and developmental Biogen products o Assesses seriousness
and expectedness for reported adverse events.
Assesses company causality for relevant adverse events
Ensures accurate coding of adverse events and serving as a
resource to the medical coding staff
Ensures due diligence in characterizing adverse events • Authors
analyses of similar events for select serious adverse reactions •
Monitors global case review activities to ensure adequate
timeliness of medical review
Liaises with program & product physicians to ensure consistency
in approach to medical review as well as ensure focused oversight
on critical areas related to ongoing safety analyses
Conduct oversight activities of global case medical review
Provides consultation for medically related questions from
participating vendors, affiliates, etc.
Qualifications Graduate of a recognized, accredited
Minimum of 3 years’ experience in a drug safety surveillance
setting within the pharmaceutical/biopharmaceutical industry or in
a clinical setting.
Additional Information All your information will be kept
confidential according to EEO guidelines.
Associate Director, ICSR-Medical Evaluation