As an Operations Specialist 1, you will be responsible for reviewing, assessing, and processing safety data across service lines, ensuring compliance with applicable regulations, Standard Operating Procedures (SOPs), and project requirements. You will work closely with internal and external stakeholders, contributing to pharmacovigilance activities and ensuring the quality and accuracy of safety data.
Key Responsibilities:
- Process safety data according to regulations, guidelines, SOPs, and project requirements.
- Perform pharmacovigilance activities, including adverse event (AE) collection, database entry, and narrative writing.
- Ensure compliance with project-related processes and quality standards.
- Collaborate with cross-functional teams to address project-related issues.
- Mentor new team members and support department initiatives.
- Participate in project team meetings and provide feedback on challenges and successes.
- Potentially perform medical review of non-serious AEs and ADRs, ensuring completeness and accuracy of data.
Qualifications:
- High School Diploma or equivalent in a scientific or healthcare discipline.
- Bachelor’s degree in life sciences or related field preferred, with up to 3 years of relevant experience, including up to 1 year of pharmacovigilance experience.
- Good knowledge of medical terminology and applicable safety databases.
- Strong attention to detail, organizational skills, and ability to work independently.
- Proficiency in Microsoft Office and web-based applications.
- Strong communication skills and ability to work effectively in a team.
- Flexibility to operate in shifts and willingness to travel occasionally.
Why Join Us?
- Opportunity to work with a global leader in advanced analytics and clinical research services.
- Engage in meaningful work that makes a real impact on global health.
- Flexible work environment with opportunities for professional growth.
