North AmericaFull TimeOther
Remotely
pharmacovigilancerisk managementclinical trialsdataregulatorysignal detectionsafety dataclinical summary of safety
Job Description
📋 Description
- Partner with stakeholders to support product safety profile, benefit risk, and signal management
- Perform standard surveillance of safety data from trials, databases, and literature.
- Collaborate with safety/clinical teams on signal assessments and regulatory requests.
- Analyze data to support signal assessment with supervision.
- Communicate surveillance findings to inform risk minimization and labeling.
- Prepare safety sections for Clinical OSRs, CSRs, and risk management plans.
🎯 Requirements
- Degree in Health Sciences (PharmD, MPH, PhD) or Masters with relevant safety experience
- Knowledge of drug development and regulatory submission processes
- Familiarity with safety data evaluation tools and SOPs
- Strong oral/written communication; manage multiple projects
- Microsoft Word/Excel and basic project management skills
- Ability to work independently under supervision
🎁 Benefits
- AbbVie comprehensive benefits package
- Paid time off, medical/dental/vision insurance
- 401(k) and long-term incentive programs
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