Associate II, Pharmacovigilance

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

📋 Description

• Accountable for the collection, processing, evaluation, and reporting of incoming Serious Adverse Event (SAE) data in accordance with relevant regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs), and specific project instructions.

• Acts as the Lead PV Associate for moderate to large studies that are moderately complex in nature, receiving moderate support from senior staff.

• Develops the Safety Management Plan for the assigned studies.

• Participates in and presents at Investigator Meetings.

• Reviews incoming SAE data to ensure completeness and accuracy.

• Conducts data entry in the Safety Database and tracks incoming safety information as necessary.

• Performs quality control on SAEs processed by other PV Associates.

• Creates regulatory reports and manages safety submissions as required.

⛳️ Requirements

• At least 3 years of experience in pharmacovigilance, specifically in pre-approval clinical trials.

• Bachelor’s degree in a science-related field, nursing, or a comparable combination of relevant education and experience.

• Proficient in computer skills with a solid understanding of MS Office applications (Excel, PowerPoint, Word).

• Exceptional written and verbal communication abilities.

• Capacity to manage multiple competing priorities while meeting applicable deadlines.

• Willingness and ability for potential limited travel (domestic and international) as required (for attending Investigator Meetings, project kick-off meetings, and/or bid defense meetings).

• Proficient in written and spoken English.

🏝️ Benefits

• A collaborative and inclusive work environment.

• Opportunities for professional development.