Manager, Safety Scientist

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

📋 Description

• Assist designated compounds alongside Product Safety Leads in executing signal detection, evaluating safety data, conducting safety risk assessments, responding to regulatory inquiries, and managing periodic reporting.

• Recognize, analyze, and assess safety data from relevant sources.

• Conduct signal detection and assessments accompanied by necessary documentation.

• Aid in data acquisition strategies and compose safety assessments.

• Collaborate with Product Safety Leads, scientists, pharmacoepidemiologists, and cross-functional teams on safety evaluations and aggregate analyses.

• Prepare and deliver safety data presentations for the Safety Management Team, Company Safety Committee, Safety Monitoring Committee, and Data Monitoring Committee/Data and Safety Monitoring Board meetings.

• Lead and facilitate safety team meetings effectively.

• Communicate pertinent safety information to core teams, business partners, and stakeholders.

• Develop, update, and review safety communication documents as necessary.

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

• Write and review safety sections for protocols, investigator brochures, informed consent forms, safety analysis plans, clinical study reports, and other related documents.

• Contribute to and review aggregate reports including PBRERs, DSURs, and PADERs.

• Support safety sections of regulatory submissions and create storyboards and briefing books for interactions with health authorities.

• Assist with investigator training and reviews of the Safety Management Plan.

• Analyze safety data and draft safety sections for regulatory inquiries and periodic reports.

• Address additional health authority evaluation requests and respond to safety inquiries from health authorities and ethics committees.

• Support integrated benefit/risk assessments.

• Carry out other tasks assigned by the manager.

⛳️ Requirements

• PharmD, RN, or PhD/MS in a medical field or biological science.

• A minimum of 2 years of experience as a Safety (Pharmacovigilance) Scientist.

• Experience in pharmaceutical product development.

• Familiarity with global regulatory requirements pertaining to pharmacovigilance.

• Proficiency in English is mandatory.

• Experience using a safety database (e.g., Argus) for retrieving safety information.

• Intermediate knowledge of MedDRA and signal management systems.

• Advanced skills in Excel, PowerPoint, Word, and electronic document management systems (e.g., Veeva).

• Acquainted with data mining and analysis tools such as Spotfire and Power BI.

🏝️ Benefits

• Equal opportunity employer.

• Less than 10% travel requirement.