Senior Safety Data Scientist

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $124.5k - $236.5k / year

⏰ Full Time

🟠 Senior

📊 Data Scientist

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Partner with cross-functional stakeholders to support product safety profiles and benefit-risk assessments throughout the product lifecycle • Conduct signal detection, signal evaluation, and prepare written and verbal summaries of signal management activities and patient-safety risks • Perform standard surveillance activities by reviewing safety data from clinical trials, safety databases, and literature • Collaborate with safety and clinical teams to develop strategies for signal assessments and regulatory requests • Analyze data from multiple sources to support signal assessments and ad hoc regulatory safety requests under supervision • Use medical judgment to determine the impact of safety issues on product benefit-risk profiles • Communicate surveillance and safety-assessment findings to product teams and leadership to inform risk-minimization activities, including label changes • Collaboratively prepare and maintain safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plans • Support development, authorship, and review of global aggregate safety reports in accordance with regulatory requirements and standard operating procedures • Prepare key safety-data summaries for PST, SRB, senior management, Advisory, and similar meetings under supervision

🎯 Requirements

• Degree in a Health Sciences field, such as Pharmacy, Epidemiology, or Nursing • Bachelor's degree plus 2 years of clinical, pharmaceutical, or safety work experience, or a master's/doctorate plus 1–2 years of clinical, pharmaceutical, or safety work experience • Knowledge of the drug development process, including clinical trials, scientific strategy and operations management, regulatory submissions, product launch, and post-marketing support • Proficiency in pharmacovigilance regulations, guidelines, and company standard operating procedures • In-depth understanding of compounds within assigned therapeutic areas, including safety profiles, labeling, literature, clinical issues, and regulatory issues • Familiarity with tools, standards, and approaches used to evaluate drug safety is desirable but not required • Experience working in a multidisciplinary, matrix team environment • Effective oral and written communication skills • Ability to manage multiple projects simultaneously • Microsoft Word and Excel skills • Basic project management skills • Ability to work independently with guidance from a manager

🏖️ Benefits

• Paid time off, including vacation, holidays, and sick leave • Medical, dental, and vision insurance • 401(k) • Eligibility to participate in long-term incentive programs