Job Description
- Performs Pharmacovigilance activities for all assigned Novartis projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of post-marketing data and Serious Adverse Events (SAEs) from clinical trials.
1.Monitors the clinical safety of projects/products and responds appropriately
2.Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications. Medical review of single case reports will be performed by associates possessing medical degree.
3.Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
4.Provides input into responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.
5 Provides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input into updates of this information.
6.Prepares medical input to aggregate clinical safety regulatory reports
7.Provides input to safety profiling and risk management plan
8.Provides guidance as appropriate to Clinical Safety Operations for the coding and causal- ity/expectedness assessment of adverse event reports.
9.Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs.
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