Pharmacovigilance Specialist

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

📋 Description

• Accountable for the collection, processing, assessment, and reporting of incoming Serious Adverse Event (SAE) data in accordance with relevant regulatory guidelines and requirements.

• Develop Safety Management Plans for assigned studies.

• Evaluate incoming SAE data for completeness and accuracy.

• Execute data entry in the Safety Database and/or manage the tracking of incoming safety information.

• Create queries for any missing or unclear information and follow up with sites to resolve issues.

• Conduct Quality Control (QC) of SAEs processed by other Pharmacovigilance Associates.

• Prepare regulatory reports and carry out safety submissions as required.

⛳️ Requirements

• A Bachelor's degree in a science-related field, nursing, or a comparable qualification.

• At least 1 year of experience in pharmacovigilance (pre-approval clinical trials).

• An equivalent blend of relevant education and experience.

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

• Exceptional written and verbal communication abilities.

• Strong organizational skills with keen attention to detail.

• Capacity to manage multiple competing priorities while adhering to deadlines.

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

• Willingness to travel occasionally (domestic and international) as necessary.

🏝️ Benefits

• Competitive benefits package based on location.

• Pay equity and transparency.