Remote Senior Scientist, Safety Data (Remote)

Description:

• The Senior Safety Data Scientist partners with cross-functional stakeholders to support the product safety profile and benefit-risk throughout the product lifecycle.
• Responsibilities include standard surveillance activities for a product’s life cycle through the review of safety data from clinical trials, safety databases, and literature.
• The role involves collaboration with safety and clinical teams to develop strategies for signal assessments and regulatory requests by analyzing data from multiple sources.
• The candidate will analyze data to support signal assessment and contribute to ad hoc regulatory safety requests with supervision.
• Medical judgment is utilized to determine the impact of identified safety issues on the compound/product’s benefit-risk profile.
• Findings from surveillance activities and safety assessments are communicated to product teams and leadership to inform necessary risk minimization activities, including label changes.
• The role includes collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plans.
• The candidate will support strategy development, authorship, and review of global aggregate safety reports in accordance with regulatory requirements and standard operating procedures with supervision.
• Summaries of key safety data for PST, SRB, senior management, Advisory, and other similar meetings will be prepared with supervision.
• Proficiency in pharmacovigilance regulations, guidelines, and company standard operating procedures is required.
• An in-depth understanding of compounds within assigned therapeutic areas, including safety profiles and relevant clinical and regulatory issues, is necessary.

Requirements:

• A degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing) is required; a Bachelor's degree with 2 years of clinical/pharma or safety work experience, or a Master's or doctorate with 1-2 years of relevant experience is acceptable.
• Knowledge of the drug development process, including conducting clinical trials and regulatory requirements for submission and product launch, is essential.
• Understanding of tools, standards, and approaches used to evaluate drug safety is desirable but not required.
• Experience working in a multidisciplinary, matrix team environment is preferred.
• Effective oral and written communication skills are necessary, along with the ability to manage multiple projects simultaneously.
• Proficiency in Microsoft WORD and EXCEL, as well as basic project management skills, is required.
• The ability to work independently with guidance from a manager is essential.

Benefits:

• AbbVie offers a comprehensive package of benefits including paid time off (vacation, holidays, sick leave), medical, dental, and vision insurance, and a 401(k) plan to eligible employees.
• This position is eligible to participate in short-term incentive programs.
• The role is also eligible for participation in long-term incentive programs.
• AbbVie is committed to diversity and inclusion, ensuring equal opportunity employment without discrimination against any employee or applicant.