Drug Safety Specialist Job at Integrated Resources, Inc ( IRI ), Plainsboro, NJ

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  • Integrated Resources, Inc ( IRI )
  • Plainsboro, NJ

Job Description

Must have :

1. Health care provider degree

2. In-depth PV case handling from case intake to submission of Individual Case Safety Reports (ICSRs)

3. Management experience

Job Requirements:

  • In-depth pharmacovigilance case handling from case intake to submission of Individual Case Safety Reports (ICSRs)
  • Extensive quality control of ICSRs to ensure compliance to internal and external health authority regulations (21 CFR FDA Post Marketing).
  • Management/Team Lead over safety case management processes/operations
  • Familiarity and experience working in safety databases (e.g. Argus)
  • identifies nonconformance and communicates via feedback or escalation as needed

Qualifications:

  • Education Level: Minimum Bachelor’s degree, HCP degree is required e.g., pharmacist or nurse; advanced degree preferred
  • Experience Level: Total of 8+ years –– 5+ Years pharmacovigilance Team Lead/Management and 3+ pharmaceutical experience, pharmacovigilance required.
  • Analytical thinker with proficiency working with safety databases
  • Proficiency in MS Outlook, Excel, Word
  • Excellent written and verbal communication skills

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