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

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

Job Description

MUST HAVES:

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 PostMarketing).

• 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

Job Tags

Part time,

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