Senior Associate, Pharmacovigilance

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

Play a critical role in patient safety by ensuring the accurate collection, evaluation, and reporting of serious adverse event (SAE) data for clinical trials. Your work will help support regulatory compliance while contributing to the development of therapies that can improve lives around the world.

As a Senior Associate Pharmacovigilance, you'll take ownership of key pharmacovigilance activities, collaborate with global study teams, and serve as the Lead PV Associate on small to moderate-sized studies. This is an opportunity to apply your scientific knowledge, attention to detail, and problem-solving skills in a fast-paced, quality-focused environment.

Working closely with internal stakeholders and external partners, you'll help ensure safety data is processed accurately, timelines are met, and reporting requirements are fulfilled to the highest standards.

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

Limited domestic and international travel may be required for investigator meetings, project kick-off meetings, and/or bid defense meetings.

• →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
  

• 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 (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting)
• Fluent in written and verbal English