Pharmacovigilance Expert
Novartis - Hyderabad, Andhra Pradesh
Author or co-authors the medical sections of PSURs including literature review and analysis of known and potential risks defined in the RMP. 3. Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR) , DSURs , Core Data Sheets (CDS) and IBs. Minimum requirements Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical Degree (MBBS or MD) Good knowledge/fluency in English.
Knowledge of other languages desirable. • 3-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral • Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred • Excellent understanding of clinical trial methodology, GCP and medical terminology • Attention to detail and quality focused • ability to operate effectively in an international environment • Excellent understanding of physiology, pharmacology, and the drug development process including its interactions with HAs • Strong technical and problem solving skills . • Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.
For more info visit at mentioned link
Novartis - Hyderabad, Andhra Pradesh
Author or co-authors the medical sections of PSURs including literature review and analysis of known and potential risks defined in the RMP. 3. Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR) , DSURs , Core Data Sheets (CDS) and IBs. Minimum requirements Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical Degree (MBBS or MD) Good knowledge/fluency in English.
Knowledge of other languages desirable. • 3-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral • Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred • Excellent understanding of clinical trial methodology, GCP and medical terminology • Attention to detail and quality focused • ability to operate effectively in an international environment • Excellent understanding of physiology, pharmacology, and the drug development process including its interactions with HAs • Strong technical and problem solving skills . • Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.
For more info visit at mentioned link
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