Drug Safety Physician III

Mindlance2

Danbury, CT, United States contract

Posted: May 16, 2016

Job Description

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com.

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.

This Job is with one of my pharmaceutical client.

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