Senior Associate, Pharmacovigilance

Worldwide Clinical Trials

. Lead pharmacovigilance activities for small to moderate-sized clinical studies with support from senior team members .

Posted 10/9/2026full-timeRemote • BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance activities, including authoring Safety Management Plans, reviewing SAE data, and preparing regulatory safety reports. Proficient in maintaining safety information within databases and ensuring compliance with applicable regulations and SOPs.

Highest-signal resume keywords

Pharmacovigilance ExperienceSafety Management PlansRegulatory ComplianceMS Office ProficiencyExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceSafety Data ReviewQuality ControlRegulatory ReportingData Management

Soft Skills

Organization SkillsAttention to DetailPrioritizationIndependent WorkTeam Collaboration

Tools & Technologies

Safety DatabasesTracking SystemsMS ExcelMS PowerPointMS Word

Industry Keywords

Clinical TrialsSAE DataSOPsStudy-Specific RequirementsGlobal Study Teams

About the role

Key responsibilities & impact

Lead pharmacovigilance activities for small to moderate-sized clinical studies with support from senior team members
Author Safety Management Plans for assigned studies to support effective safety oversight
Review incoming SAE data for completeness, accuracy, and regulatory compliance
Enter and maintain safety information within safety databases and tracking systems
Generate and manage follow-up queries to resolve missing, incomplete, or unclear safety information
Perform quality control reviews of SAE cases processed by other Pharmacovigilance Associates
Prepare regulatory safety reports and support timely safety submissions
Ensure all pharmacovigilance activities are conducted in accordance with applicable regulations, SOPs, and study-specific requirements
Collaborate with global study teams, internal stakeholders, and external partners

Requirements

What you’ll need

Bachelor’s degree in a science-related field, nursing, or an equivalent combination of education and relevant experience
Minimum of 1 year of pharmacovigilance experience supporting pre-approval clinical trials
Equivalent combination of relevant education and experience
Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
Excellent written and verbal communication skills
Excellent organization skills and attention to detail
Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines
Ability to work independently, prioritize work effectively and work successfully in matrix team environment
Ability and willingness for potential limited travel (domestic and international) as needed
Fluent in written and verbal English

Benefits

Comp & perks

Limited domestic and international travel may be required for investigator meetings, project kick-off meetings, and/or bid defense meetings
Equal employment opportunities and an inclusive environment