Drug Safety Associate
4 days ago
Job Description:
- Perform duplicate searches of cases booked in initially from the database.
- Perform data analysis on safety reports, coding all medical history, events, drugs/procedures/indications, and laboratory tests.
- Perform initial assessment of reports for listedness/expectedness and causality.
- Write and edit safety narratives of cases.
- Ensure that both the internal and regulatory timelines are met for both serious and non-serious adverse event report submissions.
- Attend internal, pharmacovigilance, and project-specific training.
- Mentor new team members as assigned by Team Lead.
- Can be cross-trained to provide support to other CGSDCI workflows for business continuity.
- Ensure that delivery and quality standards per CGSDCI KPIs are met.
- Support team and company initiatives and programs.
- Perform other ad-hoc tasks/duties as assigned by Team Lead.
General Requirement:
- License Requirement: Must hold a valid PRC license.
- Work Experience: Minimum 1 year of relevant work experience in Life Science/Healthcare fields. Work in Drug Safety within CRO is an advantage.
- Internship Eligibility: Former Interns of Celltrion are welcome to apply.
- Work Arrangement: Six (6) months onsite duty with Housing Support to eligible employees. Work-from-Home upon regularization (1x RTO/month).
- Work Schedule: Must be available to work Monday to Friday or Tuesday to Saturday after training certification.
- Shift Schedule: With fixed schedule (e.g., 6AM-3PM, 8AM-5PM, and 12NN to 9PM) based on assigned team.
- Start Date: Ready to hire on the 1st business day of each month.
Your resume submitted to us will be reviewed by CGSDCI and Celltrion, Inc., a parent company located in Korea, for evaluation purposes on a need-to-know basis. We are committed to protecting and respecting your personal data and it will be treated in accordance with our internal data protection policies.
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