Senior Scientist, Safety Data

Role Summary

Senior Scientist, Safety Data. Remote within the US. Partners with cross functional stakeholders to support the product safety profile and benefit risk through signal detection, evaluation, and preparation of summaries of signal management activities and risks to patient safety for senior management and regulatory authorities globally.

Responsibilities

• Responsible for standard surveillance activities for a product’s life cycle through review of safety data from clinical trials, safety databases, and the literature.
• Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources.
• Analyzes data to support signal assessment and contributes to ad hoc regulatory safety requests using data from multiple sources with supervision.
• Utilizes medical judgment to determine the impact of identified safety issues on the compound/product’s benefit-risk profile.
• Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes.
• Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plan.
• Support strategy development, authorship and review of global aggregate safety reports in accordance with regulatory requirements and standard operating procedures with supervision.
• Prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings with supervision.
• Proficient in pharmacovigilance regulations, guidelines, and company standard operating procedures.
• In-depth understanding of compounds within assigned therapeutic areas, including safety profile and where applicable, labeling, literature, clinical and regulatory issues.

Qualifications

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);
• Bachelor’s + 2 years clinical/pharma or safety work experience; or Master’s/doctorate with 1–2 years clinical/pharma or safety work experience (e.g., MPH, PharmD, PhD, or Masters in a Health Science).
• Knowledge of the drug development process including conducting clinical trials, scientific strategy and operations management for planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
• Understanding of tools, standards and approaches used to efficiently evaluate drug safety (desirable, not required).
• Familiar with working in a multidisciplinary, matrix team situation.
• Effective oral and written communication skills with the ability to manage multiple projects simultaneously.
• Microsoft Word and Excel skills and basic project management skills.
• Able to work independently with guidance from manager.

Skills

• Pharmacovigilance regulations and guidelines
• Data analysis for signal detection and evaluation
• Clinical trial and safety data interpretation
• Regulatory reporting and safety documentation

Education

• Degree in a Health Sciences field; advanced degree preferred depending on experience.

Additional Requirements

• Remote work eligibility within the US.