Company: IQVIA
Post: Submission Reviewer
Experience: 1-2 Yrs
Qualification: Lifesciences graduates
Location: Karnataka
Major duties and responsibilities:
- Performs regulatory reporting in all major regions in accordance with policies, SOPs and HA regulations.
- has oversight of the reporting rules configuration for compounds, marketed drugs, consumer healthcare products, 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
- 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;
- Is the SME during internal / partner audits and inspections
Skills and Education:
- Computer literacy (e.g. Microsoft Office); working knowledge of pharmacovigilance databases; strong attention to detail; ability to work independently; excellent verbal and written skills in English; understanding intake, distribution, and submission rules for ICSRs to regulatory agencies, affiliate countries, license partners/ collaboration partners.
- Able to multi-task and work under pressure to distribute and submit ICSR reports on time to prevent late distributions/submissions.
- Technical Degree preferred; 1 to 2 years of data entry experience preferred; experience working in a local/global pharmaceutical company.
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