Drug Safety Physician III

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

Title:

Drug Safety Physician III

Location:

Danbury, CT
Duration: 12 Months

• 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.

• 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.

• 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.

This job is with one of my pharmaceutical clients.