Pharmacovigilance Specialist (AM) AP

Recruiter
ADPI LLC
Location
New Haven
Salary
Competitive
Posted
Aug 13, 2017
Closes
Sep 10, 2017
Industry
Education
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Job Description

Pharmacovigilance Specialist (AM) AP

New Haven, CT 06510

12 Month Contract

*** No Subcontractors ***

Duties:

  • Does need some Argus or other Safety Databases but Argus would be better
  • CAPA not that important not a responsibility
  • Study base role
  • People Skills
  • Project Management skills
  • No case processing involved but you need to be able review a narrative but need to look in the safety database to understand what the team is doing.
  • Must have Phase studies and must have Pharmacovigilance
  • Participates in study teams/representative for PV operations
  • Authors Safety Documents including Study Safety Reporting Plans
  • Responsible for SAE Reconciliation
  • Experienced with Argus Database
  • Global regulatory reporting/compliance
  • Understanding of MedDRA coding conventions
  • Ensures follow-up & query process
  • Vendor oversight
  • Aggregate Safety Reports
  • 5+ Years of Experience
  • Specific pharmacovigilance experience (drug safety)
  • Project management
  • CAPA experience
  • Excellent communication skills

Education:

Advanced HCP degree (ie: BS Nursing, Masters degree in health related field, PharmD)

Company Description ADPI, LLC Premier IT Staffing Company dealing with LARGE Direct Clients Only.