Associate II, Pharmacovigiliance

Worldwide Clinical Trials; Brasil; Remote; BRL 329,000 - 494,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, Pharmacovigilance to lead PV activities across moderate to complex studies, ensuring accurate SAE handling and regulatory compliance. You will author plans, review data, and support safety submissions in a fast-paced, global environment.

The role is remote with collaboration across international teams. Candidates should have a science-related degree and at least 3 years of PV experience in pre-approval trials, strong regulatory knowledge, and

Qualifications

• Bachelor's degree in science or nursing with 3+ years of pharmacovigilance experience in pre-approval trials.
• Strong knowledge of medical terminology, adverse event assessment, international regulations, and safety reporting requirements.
• Experience with safety databases, relational databases, and data extraction processes.

Responsibilities

• Lead pharmacovigilance activities for moderate to large studies with safety requirements.
• Author Safety Management Plans and support study-specific safety processes.
• Review SAE data for completeness, accuracy, and regulatory compliance.
• Enter and maintain safety data within the safety database and tracking systems.
• Perform quality control reviews of safety cases.
• Generate regulatory safety reports and support safety submissions.
• Present pharmacovigilance information at Investigator Meetings and collaborate with stakeholders.
• Ensure all safety activities comply with regulations, SOPs, and instructions.

Skills

Pharmacovigilance

Regulatory compliance

Communication skills

Microsoft Office

English proficiency

Education

Bachelor's degree in science field or nursing

Tools

Safety databases

Relational databases

Data extraction

Job description

Make an Impact as an Associate II, Pharmacovigilance at Worldwide

Play a key role in patient safety by ensuring serious adverse event data is accurately collected, evaluated, and reported throughout the clinical trial process. In this position, you'll help support regulatory compliance and contribute to the delivery of high-quality safety oversight across moderate to complex clinical studies.

You'll serve as a Lead PV Associate on assigned studies, collaborating with cross-functional teams and investigators while taking ownership of critical pharmacovigilance activities. Your expertise will help ensure safety information is managed efficiently and accurately, supporting informed decision-making throughout clinical development.

Working in a fast-paced, global environment, you'll have the opportunity to apply your pharmacovigilance knowledge, attention to detail, and organizational skills to make a meaningful impact on clinical research and patient outcomes.

Where You'll Work

This is a REMOTE role open to candidates based in remote, Brazil. You will collaborate with global teams across multiple time zones.

What You'll Do

• Lead pharmacovigilance activities for moderate to large studies with moderate to complex safety requirements
• Author Safety Management Plans and support the implementation of study-specific safety processes
• Review incoming Serious Adverse Event (SAE) data for completeness, accuracy, and regulatory compliance
• Enter and maintain safety data within the safety database and applicable tracking systems
• Perform quality control reviews of safety cases processed by other Pharmacovigilance Associates
• Generate regulatory safety reports and support required safety submissions
• Present pharmacovigilance information at Investigator Meetings and collaborate with study stakeholders
• Ensure all safety activities are conducted in accordance with applicable regulations, SOPs, and project-specific instructions

What You'll Bring

• Bachelor's degree in a science-related field, nursing, or an equivalent combination of relevant education and experience, with a minimum of 3 years of pharmacovigilance experience supporting pre-approval clinical trials
• Strong knowledge of medical and scientific terminology, adverse event assessment principles, international regulations, and safety reporting requirements
• Experience working with safety databases, relational database systems, and data extraction processes
• Strong proficiency with Microsoft Office applications, including Excel, PowerPoint, and Word
• Excellent written and verbal communication skills with proficiency in English
• Strong organizational skills, attention to detail, and the ability to manage multiple priorities while meeting deadlines
• Ability to work independently, prioritize effectively, and collaborate successfully within a matrix team environment
• Demonstrated adaptability, dependability, and commitment to delivering high-quality work in a dynamic clinical research setting