Senior Associate, Pharmacovigilance

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

📋 Description

• Oversee pharmacovigilance operations for small to medium-sized clinical trials with assistance from senior colleagues.

• Develop Safety Management Plans for designated studies to ensure effective safety monitoring.

• Assess incoming Serious Adverse Event (SAE) data for thoroughness, precision, and adherence to regulatory standards.

• Input and manage safety data within safety databases and tracking systems.

• Create and oversee follow-up inquiries to address missing, incomplete, or ambiguous safety information.

• Conduct quality control evaluations of SAE cases processed by fellow Pharmacovigilance Associates.

• Compile regulatory safety reports and facilitate prompt safety submissions.

• Ensure that all pharmacovigilance tasks comply with relevant regulations, Standard Operating Procedures (SOPs), and specific study requirements.

• Collaborate with global study teams, internal stakeholders, and external partners.

⛳️ Requirements

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

• At least 1 year of pharmacovigilance experience supporting pre-approval clinical trials.

• An equivalent combination of relevant education and experience.

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

• Exceptional written and verbal communication abilities.

• Strong organizational skills and meticulous attention to detail.

• Proven capability to manage multiple competing priorities while meeting deadlines.

• Ability to work independently, effectively prioritize tasks, and succeed in a matrix team environment.

• Willingness and ability for potential limited travel (both domestic and international) as necessary.

• Proficient in written and spoken English.

🏝️ Benefits

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

• Equal employment opportunities and a commitment to fostering an inclusive environment.