Senior Associate, Pharmacovigilance - Japan

Job Title: Senior Associate, Pharmacovigilance - Japan (Remote)

Job Location: Virtual Japan

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Who we areWe’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 over 3,500+ 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.

Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What Pharmacovigilance department does at Worldwide

Pharmacovigilance is the gateway to ensuring drug safety!  Our Pharmacovigilance team comprises a dynamic group of individuals with extensive experience within the Drug Safety world. Watching drugs progress from First in Human Administration to global regulatory approval, we can be a part of the entire lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze, and submit to Investigators, Ethics Committees/IRBs, and Regulatory Agencies furthering clinical drug development!

What you will do

• Author Safety Management Plan for assigned studies

• Attend internal and client meetings as appropriate

• Attend and present at Investigator Meetings

• Review incoming SAE data for completeness and accuracy

• 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

• Perform QC of SAEs processed by other PV Associates

• Generate regulatory reports and perform safety submissions as needed

• Prepare and submit periodic safety reports as needed

• Maintain knowledge and understanding of safety related regulations and guidelines

• Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope

• May assist with bid defences or other presentations

• May mentor or train new PV staff

• Perform other duties as assigned

What you will bring to the role

• Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements

• Excellent 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

• Ability to anticipate needs and follow through on all assigned tasks

• Able to effectively receive and provide constructive feedback without becoming defensive

• Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame.

• Good understanding of computer technology, and management of relational database systems, including extract...