South San FranciscoFull TimeOther
Remotely
pharmacovigilanceregulatory submissionsdatamicrosoft excelmicrosoft wordsignal detectionclinical study reportssafety datarisk management plan
Job Description
📋 Description
- Lead surveillance activities for products across lifecycle using data from trials, safety
- Collaborate with safety/clinical teams to plan signal assessments and regulatory requests.
- Analyze data for signal assessment and prepare materials for ad hoc regulatory safety requests.
- Communicate safety findings to inform risk minimization and labeling decisions.
- Prepare and maintain safety sections of Clinical CS, CSRs, CDSS, and Risk Management Plans.
🎯 Requirements
- Degree in Health Sciences or relevant advanced degree; or equivalent combination of education and
- Knowledge of drug development, regulatory requirements, and safety science integration.
- Experience with safety data evaluation methods and cross-functional collaboration.
- Strong oral/written communication and ability to manage multiple projects.
- Proficiency in Microsoft Word and Excel; basic project management; independent work capability.
🎁 Benefits
- AbbVie offers a comprehensive benefits package including PTO, medical/dental/vision, and 401(k).
- Eligibility for long-term incentive programs; equal opportunity employer commitments.
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