Pharmacovigilance Specialist - US - Remote

About the role

At Worldwide, we are a global CRO with over 3,500 experts dedicated to improving lives through innovative approaches and quality. We are committed to creating a diverse and inclusive environment where professionals can thrive.

Responsibilities

• Author Safety Management Plan for assigned studies
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and/or track safety information
• Generate queries for missing or unclear information and follow up with sites for resolution
• Generate regulatory reports and perform safety submissions as needed

Requirements

• Good understanding of medical and scientific terminology, regulatory guidelines, and reporting requirements
• Strong understanding of computer technology and management of relational database systems
• Positive attitude and ability to interact professionally with internal and external customers
• Excellent organization skills and ability to handle multiple priorities within tight timelines
• Commitment to teamwork, adaptability, and flexibility

Qualifications

• Bachelor’s degree in a science-related field, nursing, or equivalent
• Minimum of 1 year of pharmacovigilance experience (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 collaborate in a matrix team environment
• Willingness for potential limited travel (domestic and international) as needed (attend Investigator Meetings, project kick-off meetings, and/or bid defense meetings)
• Fluent in written and verbal English

Skills

• Understanding of medical and scientific terminology
• Knowledge of regulatory guidelines and reporting requirements
• Proficiency in computer technology and database management
• Effective communication and interpersonal skills
• Organizational and time management skills

Benefits

We are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually:

• United States of America - $50,000.00 - $99,000.00

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it is not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity.

In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws.