Drug Safety Associate

4 days ago


Manila, National Capital Region, Philippines Celltrion Global Safety Data Center Inc. Full time

Job Description:

  1. Perform duplicate searches of cases booked in initially from the database.
  2. Perform data analysis on safety reports, coding all medical history, events, drugs/procedures/indications, and laboratory tests.
  3. Perform initial assessment of reports for listedness/expectedness and causality.
  4. Write and edit safety narratives of cases.
  5. Ensure that both the internal and regulatory timelines are met for both serious and non-serious adverse event report submissions.
  6. Attend internal, pharmacovigilance, and project-specific training.
  7. Mentor new team members as assigned by Team Lead.
  8. Can be cross-trained to provide support to other CGSDCI workflows for business continuity.
  9. Ensure that delivery and quality standards per CGSDCI KPIs are met.
  10. Support team and company initiatives and programs.
  11. Perform other ad-hoc tasks/duties as assigned by Team Lead.

General Requirement:

  1. License Requirement: Must hold a valid PRC license.
  2. Work Experience: Minimum 1 year of relevant work experience in Life Science/Healthcare fields. Work in Drug Safety within CRO is an advantage.
  3. Internship Eligibility: Former Interns of Celltrion are welcome to apply.
  4. Work Arrangement: Six (6) months onsite duty with Housing Support to eligible employees. Work-from-Home upon regularization (1x RTO/month).
  5. Work Schedule: Must be available to work Monday to Friday or Tuesday to Saturday after training certification.
  6. Shift Schedule: With fixed schedule (e.g., 6AM-3PM, 8AM-5PM, and 12NN to 9PM) based on assigned team.
  7. 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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