Pharmacovigilance Operations Specialist
Develop Innovative New Drugs at a Leading Global Contract Research Organization
Contribute the Safety and Wellness of Patients Globally
- Leading US based human data science company focused utilizing big data analysis and extensive clinical trial expertise to identify unparalleled insights and better solutions for patients.
- Proactively providing case processing activities as requested to ensure high-quality individual case safety reports of adverse events
- Provide accurate individual case reports for submission to regulatory authorities, sponsors and and participating clinical trial investigators in compliance with regulatory requirements and time frames for reporting.
- Serve as a member of project teams. Communicate timelines, delivering quality and timely input to meet the needs of the project team and informs the project team on the status of activities and issues.
- Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes
- Revises and maintains processes and procedures for drug safety in compliance with regulatory requirements and company standards.
- Support Pharmacovigilance Audits and Inspections as needed concerning the Global Case Management function.
- Any other activity that may reasonably be required.
Hands-on experience in pharmacovigilance case processing (data entry, triage, evaluation, QC, submission).
Japanese language proficiency of business level
Ability to prioritize, time line management
Ability to read and write short sentences using English dictionaries
Associate degree or higher
Nice to have: any leadership experience in pharmacovigilance. (e.g. OJT, SOP renewal, system update, managing timeline and quality)
Nice to have: English proficiency: TOEIC 600 or equivalent
Nice to have: Ability to make good relationship with stakeholders, leadership
Nice to have: Medical background (Medicine, Pharmacy, Medical Technology, Nursing, etc)
- Opportunity to build leadership skills and move into a management position
- Opportunity to work on a large number of diverse projects to develop a broad range of IMPs
- Work on global studies at an industry leading international company