Pharmacovigilance Associate - Japan - Homebased
Multiple Locations: Tokyo, Japan • Osaka, Japan • Japan
Requisition Number: 6983
Position Title: Associate, Pharmacovigilance
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 3,000+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What you will do
- Author Safety Management Plan for assigned studies. Attend internal and client meetings as appropriate and present at Investigator Meetings
- Review incoming SAE data for completeness and accuracy. Perform QC of SAEs processed by other PV Associates
- Perform data entry in the Safety Database and/or complete applicable tracking of incoming 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. Prepare and submit periodic safety reports as needed
What you will bring to the role
- Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
- Good understanding of computer technology, and management of relational database systems, including extraction of data
- Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment
- Excellent organization skills and ability to handle multiple competing priorities within tight timelines
- Bachelor’s degree in a science-related field, nursing, or equivalent
- Minimum of 3 years of pharmacovigilance experience (pre-approval clinical trials)
- Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
- Excellent written and verbal communication skills
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Employment Type: Regular
Community / Marketing Title: Pharmacovigilance Associate - Japan - Homebased
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Tokyo, JP