Senior Associate - Medical Review Physician (RRD)
ClinChoiceBengaluruFull TimeHealthcare
Remotely
pharmacovigilanceregulatory compliancesafetyich gcpmeddragvppv21 cfr
Job Description
📋 Description
- Awareness and understanding of relevant GVP modules.
- Perform medical review of non-serious & serious ICSRs with emphasis on seriousness
- Experience of medical review of ICSRs received from sources such as Spontaneous, Literature
- Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology
- Support triage of cases and determine seriousness and relatedness across products as assigned.
- Review and verify appropriate selection of adverse events from source documents, assign appropriate
🎯 Requirements
- Should be a MBBS/MD with 2- 4 years of experience as Medical Reviewer for ICSRs.
- Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other
- Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product
- Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc)
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