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Iqvia Biotech
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Submission Reviewer

Submission Reviewer

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Iqvia Biotech

1 - 3 years

2 - 5 Lacs

Kolkata

Posted:1 day ago| Platform:

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Skills Required

Training Regulatory reporting Investigation Database Clinical research Healthcare Life sciences Operations Monitoring Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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. Monitor Distribution mailbox and take appropriate action as per the received emails. 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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Iqvia Biotech

Pharmaceuticals / Biotechnology

Nashville

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Submission Reviewer