Medical Safety Expert Jobs in Hyderabad at Novartis Healthcare Private Limited

Last Updated: Apr 28, 2021 05:10 IST

JOB DETAILS

Company Name
Novartis Healthcare Private Limited
Job title
Medical Safety Expert
Role
Education
Location
Experience
1-3 Years
Salary
Not Mentioned

Job Profile

Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. 
-Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. 
-Perform literature review 
-Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests. -Perform follow up activities on Health Authority Assessment Reports.
 -Assist in providing safety input to Regulatory Affairs and clinical documents. Support maintenance and management of local deviations 
-Assist in evaluating and writing other safety deliverables as assigned -Provide support as needed for new indication submission (regulatory document safety input). 
-Prepare responses to internal safety requests and contribution to responses to external safety queries.
-Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function -Lead the training and mentoring of junior team members/colleagues

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OTHER DETAILS

Key skills
Pharmacovigilance Physician, ICSR
Industry
Pharmaceutical
Summary
Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs
Last Date
2021-06-25

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