Bangalore
Processing of the Individual Case Safety Reports (ICSR) from all sources in compliance with
applicable regulations. Focusing on Triage and Data Entry.
Performing Quality Review of the Individual Case Safety Reports (ICSR) processed by the
Data Entry team.
Performing Medical Review of the Individual Case Safety Reports (ICSR).
Literature screening activities. Accountable for reviewing and assessing the validity of
literature abstracts and articles with further processing onto the safety database if required.
Maintain a PSUR schedule and preparation of Periodic Safety Update Reports (PSUR’s).
Preparation and review of Risk Management Plans.
Preparation and review of Addendum to Clinical Overviews.
Preparation of Risk Assessment Reports.
Experience | 2 - 4 Years |
Salary | 4 Lac 75 Thousand To 5 Lac P.A. |
Industry | Health Care / Pharmaceuticals / Medical |
Qualification | Professional Degree |
Key Skills | Risk Management ICSR Pharmacovigilance |
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