Senior Safety Data Scientist

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

📋 Description

• Collaborate with cross-functional teams to assist in evaluating product safety profiles and conducting benefit-risk assessments throughout the product lifecycle.

• Carry out signal detection and evaluation, and prepare both written and verbal summaries regarding signal management activities and patient safety risks.

• Execute standard surveillance tasks by analyzing 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 fulfill ad hoc regulatory safety requests under supervision.

• Apply medical judgment to assess the impact of safety concerns on product benefit-risk profiles.

• Relay findings from surveillance and safety assessments to product teams and leadership to guide risk-minimization efforts, including potential label modifications.

• Jointly prepare and maintain safety sections of Clinical Summary 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 in compliance with regulatory standards and company procedures.

• Compile key safety data summaries for PST, SRB, senior management, Advisory, and similar meetings under supervision.

⛳️ Requirements

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

• Bachelor's degree accompanied by 2 years of clinical, pharmaceutical, or safety work experience, or a master's/doctorate with 1–2 years of relevant experience.

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

• Competence in pharmacovigilance regulations, guidelines, and company standard operating procedures.

• Thorough understanding of compounds within assigned therapeutic areas, including their safety profiles, labeling, literature, clinical issues, and regulatory considerations.

• Experience with tools, standards, and methods used to assess drug safety is advantageous but not mandatory.

• Background in working within a multidisciplinary, matrix team environment.

• Strong oral and written communication skills.

• Capability to manage multiple projects concurrently.

• Proficient in Microsoft Word and Excel.

• Basic project management abilities.

• Capacity to work independently with guidance from a manager.

🏝️ Benefits

• Paid time off, which includes vacation days, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Eligibility to take part in long-term incentive programs.