Pharmacovigilance Expert 3 - 6 YearsHyderabad / Secunderabad - UG -MBBS - Medicine PG - M.S/M.D - Any Specialization Doctorate - Doctorate Not Required "D"

Pharmacovigilance Expert

3 - 6 YearsHyderabad / Secunderabad

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Job Description

Provide support to the IMS Department in the single case medical review and associated activities as needed such as Periodic Safety Update Report (PSUR), coordinating the management of large datasets for analysis purposes, responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating proce-dures and global and local regulatory requirements. 1. Performs single case medical review in the safety database or on line listings Of Oncology marketed products. 2. 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.

Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Officer
Role: Medical Officer
Keyskills: Pharmacovigilance Expert, Pharmacovigilance, Medical, Medical Officer, DSURs, MedDRA

Desired Profile

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.
Education:UG -MBBS - Medicine
PG - M.S/M.D - Any Specialization
Doctorate - Doctorate Not Required

Company Profile

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.

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