Submission Reviewer

2 hours ago


Remote, India IQVIA Full time

Major duties and responsibilities:
Submission Reviewer is a centralized role that:

- Has oversight of the reporting rules configuration for compounds, marketed drugs,

devices, and vaccines to ensure proper distribution / submission to health authorities,
affiliate countries, license partners / collaboration partners.
- Has regulatory reporting expertise in all major regions.
- Performs regulatory reporting in all major regions in accordance with policies, SOPs

and HA regulations. Has oversight of ICSR submission related activities in all regions,
ensuring safety database is operational, prompt escalation of system outage affecting
ICSR distribution / submission process.
- Distribution of “Dear investigator letter” to investigators.
- Is the SME during internal / partner audits and inspections.
- Provide or receive training on Customer-specific processes, systems, or products.
- Other tasks as required.



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