Associate Director, Safety Scientist

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

📋 Description

• Concentrate on early development (phase I) and late-stage (phase II–III) safety science initiatives.

• Execute safety assessments and manage safety risks according to ICH standards.

• Offer safety expertise for designated developmental and/or marketed products alongside Product Safety Physician Leads and Safety Physicians.

• Act as a representative for the GPS department both internally and externally on a global scale.

• Oversee signal evaluation and safety monitoring tasks.

• Contribute to pharmacovigilance, benefit/risk assessments, and regulatory activities and communications.

• Identify, analyze, and assess safety signals from both internal and external data sources.

• Guide data acquisition strategies and conduct safety data analyses; draft safety assessment reports.

• Collaborate with PSLs, scientists, pharmacoepidemiologists, and cross-functional teams on aggregate safety evaluations.

• Prepare and present safety data for the Safety Management Team, Company Safety Committee, SMC, DMC, and DSMB meetings.

• Develop, revise, and evaluate safety communication documents and labeling materials.

• Review safety data and ensure patient safety during assigned clinical trials.

• Draft and review safety sections for protocols, IBs, ICFs, SAPs/TFLs, Medical Monitoring Plans, CSRs, and other study-related documents.

• Author and review safety sections in regulatory submissions and responses to regulatory inquiries.

• Create storyboards and briefing books for interactions with health authorities.

• Maintain Safety Management Plans and lead Safety Science-specific investigator training sessions.

• Analyze safety data and write safety sections for periodic reports, including DSURs and PADERs.

• Perform additional departmental tasks as assigned by the manager.

⛳️ Requirements

• PharmD or PhD in a medical field or biological science with over 4 years of experience in pharmacovigilance in an analytical capacity, OR RN with over 8 years in pharmacovigilance in an analytical role, OR MD (or an internationally recognized equivalent) with an accredited residency or similar post-medical-school clinical training.

• Minimum of 4 years of clinical experience with patients in a relevant therapeutic-area specialty.

• Extensive knowledge of general medicine.

• Preferably 2+ years of experience in the pharmaceutical/biotechnology industry within Safety Science, Clinical Development, or Clinical Research.

• US-trained physicians must have achieved board eligibility or certification.

• Physicians trained outside the US who are not board eligible or certified may be employed in the US at the discretion of the Chief Safety Officer or an appropriate delegate.

• Intermediate proficiency in utilizing a safety database for retrieving safety information.

• Advanced knowledge of MedDRA.

• Strong application skills with Excel, PowerPoint, and Word.

• Familiarity with data mining and exploratory analysis tools like Spotfire.

• Willingness to travel less than 10% of the time.

🏝️ Benefits

• Full-time employment.

• Opportunity for remote work.

• Travel requirements of less than 10%.

• Commitment to equal opportunity employment.