What are the responsibilities and job description for the Drug Safety Public Health Coordinator - I-10909 position at Leadstack Inc?
Adhere to guidelines that Operations sets on work priorities with input from Manager.
Responsible for submission support duties include but are not limited to data review, data entry, regulatory submissions of ICSR (Individual Case Safety Report) and aggregate reports to health agencies and third parties.
Have a basic knowledge of global regulatory reporting requirements.
Demonstrate consistency and accuracy in output of handling high volume workload and execute stringent deadlines to meet department’s compliance.
Able to organize and prioritize work load independently utilizing workload resources.
In addition to maintaining designated assignments, the candidate should be multi-tasked oriented and be able to take part in department projects which may require cross-training to handle other functions per need basis.
Recognize situations that require escalation and request assistance promptly from senior staff. Remain current with SOPs (Standard Operating Procedures), procedural and training documents, and database technology.
Ensures compliance with SDEA (Safety Data Exchange Agreement) and other global regulatory reporting requirements for ICSR.
Job Types: Full-time, Contract
Schedule:
- 8 hour shift
Work Location: One location