Drug Safety Physician III

Title: Drug Safety Physician III
Location: Danbury, CT
Duration: 12 Months

Responsibilities

•    Must have experience with review and interpretation of aggregate data, signal management, and optimally with authoring regulatory responses and PV-related documents for NDA submissions.
•    In addition to reviewing and interpreting aggregate data, may be responsible for assessing individual clinical trial and spontaneous case reports for medical review and determining regulatory reporting responsibilities; assessing seriousness, expectedness and causality; and querying for additional medical information needed to understand the event and determine causality
Requirements:
•    Skills: MEDICAL CLEARANCES - Experience with complex PV analyses and authoring PV-related regulatory documents required
•    INDUSTRY EXP: Five years industry pharmacovigilance/risk mgmt and aggregate analysis of safety data Clinical Medicine experience with more than one year of patient care. Excellent written & verbal communication skills
•    Must have MD / DO and Medical license (US or equivalent) plus at least 1 year post license clinical experience.

•    Skills: MEDICAL CLEARANCES - Experience with complex PV analyses and authoring PV-related regulatory documents required
•    INDUSTRY EXP: Five years industry pharmacovigilance/risk mgmt and aggregate analysis of safety data Clinical Medicine experience with more than one year of patient care. Excellent written & verbal communication skills
•    Must have MD / DO and Medical license (US or equivalent) plus at least 1 year post license clinical experience.