Accountabilities:

• Lead the identification, analysis, evaluation, and documentation of safety signals using multiple internal and external data sources.
• Develop and lead appropriate data acquisition strategies, analytical methodologies, and approaches for safety evaluations.
• Analyze aggregate safety data and author comprehensive safety assessment reports, applying sound scientific judgment to identify potential risks and their implications.
• Collaborate with Safety Physicians, Product Safety Physician Leads, scientists, pharmacoepidemiologists, and other cross-functional experts to conduct thorough safety assessments.
• Lead the preparation and presentation of safety data for Safety Management Teams, Company Safety Committees, Safety Monitoring Committees, Data Monitoring Committees, and Data and Safety Monitoring Boards.
• Facilitate safety team meetings and communicate relevant safety information clearly and promptly to core teams, business partners, and key stakeholders.
• Lead the development, review, and maintenance of safety communication materials, including investigator communications, informed consent documents, Investigator’s Brochures, healthcare professional communications, labeling documents, and Risk Management Plans.
• Ensure signal detection and assessment activities are performed according to applicable regulations, established processes, and quality standards.
• Lead safety monitoring activities for assigned clinical trials and provide scientific expertise in the evaluation of patient safety data.
• Author and review safety sections of clinical and study documents, including protocols, Investigator’s Brochures, informed consent forms, statistical analysis plans, data displays, medical monitoring plans, and clinical study reports.
• Provide safety expertise for regulatory submissions, including IND/CTA and NDA/MAA-related materials, working closely with Safety Physicians and cross-functional study teams.
• Lead the preparation of storyboards, briefing books, and other materials supporting health authority interactions.
• Develop and maintain Safety Management Plans and lead Safety Science-specific investigator training activities.
• Analyze safety data and author relevant sections of regulatory inquiries and periodic safety reports, including DSURs and other applicable pharmacovigilance reports.
• Contribute to benefit-risk assessments, regulatory activities, safety risk management, and the continuous advancement of pharmacovigilance practices.
• Apply sound judgment and scientific reasoning to key clinical and safety discussions, while communicating complex issues effectively to diverse audiences.

Requirements:

• PharmD or PhD in a medical field or biological science with 4+ years of experience in an analytical pharmacovigilance role.
• Alternatively, an RN with 8+ years of experience in an analytical pharmacovigilance role.
• Alternatively, an MD or internationally recognized equivalent, with accredited residency or comparable postgraduate clinical training, relevant clinical experience, and significant knowledge of general medicine.
• For physician candidates, experience in a relevant therapeutic area and at least 2 years of pharmaceutical or biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.
• Strong practical knowledge of pharmacovigilance, safety signal detection, safety assessment, and risk management.
• Demonstrated experience analyzing clinical and safety data and translating findings into scientifically sound recommendations.
• Strong knowledge of applicable pharmacovigilance regulations, ICH standards, and clinical safety requirements.
• Advanced knowledge of MedDRA and experience working with safety databases to retrieve and evaluate safety information.
• Familiarity with data-mining and exploratory analysis tools such as Spotfire.
• Advanced proficiency with Microsoft Excel, PowerPoint, and Word.
• Strong scientific writing and presentation capabilities, with the ability to communicate complex safety information clearly and concisely.
• Ability to collaborate effectively within matrix organizations and influence cross-functional stakeholders without direct authority.
• Strong judgment, analytical thinking, attention to detail, and decision-making skills.
• Ability to lead safety discussions, facilitate meetings, and confidently present findings to senior stakeholders and governance committees.
• Fluent English is required.
• Willingness to travel occasionally, with expected travel of less than 10%.

Benefits:

• Fully remote work opportunity from Brazil.
• Full-time position within a global, cross-functional pharmacovigilance environment.
• Opportunity to contribute to safety science activities spanning Phase I through Phase III clinical development.
• High visibility through participation in safety governance forums, regulatory activities, and cross-functional decision-making.
• Opportunities to collaborate with international Safety, Clinical Development, Regulatory, Medical, and scientific teams.
• Professional growth through exposure to complex safety assessments, emerging pharmacovigilance practices, and global regulatory activities.
• Opportunity to contribute directly to patient safety and benefit-risk decision-making for innovative therapies.
• The original job posting does not specify salary, healthcare coverage, bonus structure, or additional benefits; these details should be confirmed during the hiring process.