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Drug Safety Physician III
Danbury, CT, United StatesPosted 123 months ago
ContractonsiteMid-Senior Level
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 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.
• 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.
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.
• 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.