Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at Job Description 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 optimizing authoring of 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 experience: Five years in industry pharmacovigilance/risk management 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-licence clinical experience. Qualifications Skills: MEDICAL CLEARANCES – experience with complex PV analyses and authoring PV-related regulatory documents required. Industry experience: 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-licence clinical experience. Additional Information This job is with one of my pharmaceutical clients. #J-18808-Ljbffr Mindlance
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