Senior Pharmacovigilance Data Scientist

AbbVie

Florham Park (NJ)

On-site

USD 125,000 - 237,000

Full time

2 days ago
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Benefits offered by this job

Benefits package
Long-term incentives

Job summary

AbbVie in Florham Park, NJ, seeks a pharmacovigilance professional to manage signal detection and risk summaries across product lifecycles, presenting to senior management and regulatory authorities globally.

You will review safety data from trials and literature, collaborate with safety and clinical teams, and prepare safety sections for CSOs, SSRS, and RMPs. Strong communication and ability to work in a matrix environment are essential.

Qualifications

  • Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
  • Knowledge of drug development process incl. clinical trials and regulatory requirements.
  • Experience with tools/standards for drug safety evaluation is desirable.

Responsibilities

  • Conduct routine safety surveillance across product lifecycles using trial data, safety databases, and literature.
  • Collaborate with safety and clinical teams to develop signal assessments and regulatory requests.
  • Analyze data to support signal assessment and respond to regulatory safety requests under supervision.
  • Evaluate impact of identified safety issues on product benefit-risk using medical judgment.
  • Prepare summaries for PST, SRB, and leadership meetings with supervision.
  • Maintain knowledge of pharmacovigilance regulations and SOPs.

Skills

Pharmacovigilance
Data analysis
Communication skills
Independent worker
Multidisciplinary teamwork

Education

Health Sciences degree
Bachelor's + 2 years experience
Master/PhD in health science

Tools

Microsoft Word
Microsoft Excel

Job description

AbbVie in Florham Park, NJ, seeks a pharmacovigilance professional to manage signal detection and risk summaries across product lifecycles, presenting to senior management and regulatory authorities globally.

You will review safety data from trials and literature, collaborate with safety and clinical teams, and prepare safety sections for CSOs, SSRS, and RMPs. Strong communication and ability to work in a matrix environment are essential.

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