Job Description
- Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
- Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
- Provide vendors with resources and training to perform their role
- Analysis and communication of case Quality Control results
- Responsible for escalation of case related issues from vendor(s)
- Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
- Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
- May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
- Other duties relate...
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