Senior Safety Data Scientist

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

📋 Description

• Collaborate with cross-functional stakeholders to assist in the evaluation of product safety profiles and benefit-risk assessments throughout the product lifecycle.

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

• Conduct routine surveillance activities by analyzing safety data from clinical trials, safety databases, and relevant literature.

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

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

• Utilize medical judgment to evaluate 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 label modifications.

• Jointly prepare and sustain 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 under supervision.

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

⛳️ Requirements

• A degree in a Health Sciences field (e.g., Pharmacy, Epidemiology, Nursing).

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

• Understanding of the drug development process, which includes 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.

• Comprehensive knowledge of compounds in assigned therapeutic areas, encompassing safety profiles and relevant labeling, literature, clinical, and regulatory considerations.

• Familiarity with tools, standards, and methods for drug safety evaluation is a plus, though not mandatory.

• Acquaintance with multidisciplinary, matrix-team environments.

• Strong oral and written communication skills.

• Capability to manage multiple projects concurrently.

• Proficient in Microsoft Word and Excel.

• Basic project management skills.

• Ability to work independently while receiving guidance from a manager.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility to participate in long-term incentive programs.