Associate Director, Safety Scientist

About This Opportunity

We are representing a confidential biotechnology client seeking an Associate Director, Safety Scientist in Brazil. Our client is a global, commercial-stage organization focused on oncology therapeutics with operations across multiple continents. This role offers the opportunity to contribute to meaningful drug safety evaluation for novel cancer treatments in both early and late-stage development.

Language Requirement: Fluent English is required. Please submit all application materials in English.

Preferred Background: Pharmaceutical or biotech industry experience

Responsibilities

As Associate Director, Safety Scientist, you will lead critical safety evaluation activities for assigned development and marketed oncology products:

• Signal Detection and Safety Data Evaluation: Lead identification, analysis, and evaluation of safety signals from multiple data sources; propose data acquisition strategies and methodologies; author safety assessment reports and present findings to governance committees
• Clinical Trial Support: Lead review of safety data for allocated clinical trials; write and review safety sections of Protocols, Investigator's Brochures, Informed Consent Forms, Statistical Analysis Plans, Clinical Study Reports, and other study documents
• Regulatory Documentation: Author safety sections of regulatory submissions including INDs/CTAs, NDAs/MAAs, Safety Communication documents, Risk Management Plans, and labeling materials
• Cross-functional Collaboration: Work closely with Product Safety Physician Leads, Safety Physicians, pharmacoepidemiologists, and matrix teams to ensure thorough safety evaluation and aggregate analysis
• Committee Presentations: Prepare and present safety data for Safety Management Teams, Safety Monitoring Committees, Data Monitoring Committees, and Data Safety Monitoring Boards
• Periodic Reporting: Lead authoring of Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports, and responses to regulatory inquiries
• Training: Lead Safety Science-specific investigator training sessions

This position has no direct reports but functions as a key member of matrix safety teams conducting safety assessment and risk management activities based on ICH standards.

What We're Looking For

Required Education (one of the following):

• PharmD or PhD in a medical field or biological science with 4+ years of pharmacovigilance experience in an analytical role
• RN with 8+ years in pharmacovigilance in an analytical role
• MD (or internationally recognized equivalent) with completed accredited residency or comparable post-medical school clinical training; 4+ years of clinical experience with patients in relevant therapeutic specialty with significant knowledge of general medicine; 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research preferred

Technical Skills:

• Intermediate knowledge working with safety databases for retrieval of safety information
• Advanced knowledge of MedDRA coding terminology
• Advanced proficiency with MS Office Suite (Excel, PowerPoint, Word)
• Familiarity with data mining and exploratory analysis tools such as Spotfire

Core Competencies:

• Strong scientific writing and communication skills with ability to lead and facilitate team meetings
• Judgment-based decision-making abilities for key scientific and clinical discussions
• Analytical thinking and data analysis capabilities
• Collaborative mindset with ability to work effectively across functions and geographies
• Results-oriented approach with demonstrated initiative

Travel: Less than 10%

How We Work with You

Get A Job.ai represents this confidential client exclusively for this search. When you apply through our platform:

• Our specialized recruiting team will review your credentials and conduct an initial screening
• Qualified candidates will be presented directly to our client for consideration
• We'll guide you through each stage of the interview process and provide feedback
• Please do not attempt to contact the client directly, as all applications must come through Get A Job.ai to be considered

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applications from candidates of all backgrounds and do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other protected characteristic.