Senior Safety Data Scientist

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Collaborate with cross-functional stakeholders to enhance product safety profiles and conduct benefit-risk assessments throughout the product lifecycle.

• Execute signal detection and evaluation, and prepare both written and verbal summaries of signal management activities and patient safety risks.

• Carry out standard surveillance activities by reviewing safety data from clinical trials, safety databases, and relevant literature.

• Work alongside safety and clinical teams to devise strategies for signal assessments and regulatory inquiries.

• Analyze data from various sources to aid in signal assessments and respond to ad hoc regulatory safety requests under supervision.

• Utilize medical judgment to evaluate the impact of safety issues on the benefit-risk profiles of products.

• Convey findings from surveillance and safety assessments to product teams and leadership.

• Inform necessary risk-mitigation activities, including modifications to labels.

• Collaboratively create and maintain safety sections of Clinical Summaries of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plans.

• Assist in the development, authorship, and review of global aggregate safety reports.

• Generate key safety data summaries for product safety, safety reviews, senior management, advisory meetings, and similar forums.

⛳️ Requirements

• A degree in a Health Sciences field, such as Pharmacy, Epidemiology, or Nursing.

• A bachelor's degree with 2 years of clinical, pharmaceutical, or safety experience; or a master's/doctorate with 1–2 years of clinical, pharmaceutical, or safety experience.

• Familiarity with the drug development process, including clinical trials, scientific strategy, operations management, regulatory submissions, product launch, and post-marketing support.

• Proficiency in Microsoft Word and Excel.

• Basic project management capabilities.

• Knowledge of pharmacovigilance regulations, guidelines, and company standard operating procedures.

• Comprehensive understanding of compounds in designated therapeutic areas, including safety profiles, relevant labeling, literature, clinical, and regulatory matters.

• Experience with tools, standards, and methodologies for evaluating drug safety is a plus but not mandatory.

• Capability to work in a multidisciplinary, matrix-team environment.

• Excellent oral and written communication skills.

• Ability to manage multiple projects simultaneously.

• Capacity to work independently with managerial guidance.

🏝️ 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.