Main Job Tasks and Responsibilities:
- Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
- Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database.
- Experience in ARGUS database.
- Experience in rare disease portfolio.
- Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
- Training and mentoring skill (ICSR, Safety database, etc.)
Education, Experience and Skills:
- Master’s in Science or above and in alignment with project/business team requirements.
- Minimum of 5 to 7 years of relevant experience in identified functional domain/business workstream.
- Must have hands on experience with MS office applications (Outlook, Excel, Word, PowerPoint, etc.).
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!