North AmericaFull TimeOther
Remotely
data analysispharmacovigilancedataregulatorylabeling
Job Description
📋 Description
- This position partners with cross functional stakeholders in support of the product safety profile
- Responsible for standard surveillance activities for a product’s life cycle through review of
- Collaborates with safety and clinical teams to develop strategies and approaches for signal
- Analyzes data to support signal assessment and contributes to ad hoc regulatory safety requests
- Utilizes medical judgment to determine the impact of identified safety issues on the compound/
- Communicates findings of surveillance activities and safety assessments to product teams and
🎯 Requirements
- Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing); or Bachelors + 2 years
- Knowledge of the drug development process including clinical trials, regulatory submission, and
- Understanding of tools and approaches to evaluate drug safety; familiarity with multidisciplinary
- Effective oral and written communication with ability to manage multiple projects
- Microsoft Word and Excel skills and basic project management skills
- Able to work independently with guidance from manager
🎁 Benefits
- Competitive compensation and comprehensive benefits package
- Eligible for long-term incentive programs
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