ClinChoice | Safety Surveillance Scientist | india
7 days ago
Key Roles and Activities: Senior Surveillance Scientist:
The Senior Surveillance Scientist will support the Signal Tracking Team and safety and quality systems, by performing activities such as, but not limited to:
- Attention to detail and ability to analyze data in a broader context
- Ability to understand the nature of adverse drug reactions and complex associations
- Ability to perform aggregate safety analysis and case level review.
- Performance of ad hoc data mining activities in external safety databases (e.g., FAERS, VigiBase, EudraVigilance) utilizing Empirica Signal and EudraVigilance data analysis system (EVDAS).
- Performance of safety data assessment through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as clinical, post-marketing, observational studies, medical literature, health authority databases, and product quality databases.
- Identification and validation assessment of safety signals
- Act as SMT member and provide SMT presentations as support
Qualification & Experience Requirements:
- A minimum of two years of post-marketing safety and/or epidemiology experience; five years of relevant experience is preferred
- Advanced degree (e.g., MD, MPH, PharmD) in life sciences or health-care discipline preferred
- Degree (e.g., B.S., B.S.N.) in life sciences or health-care discipline
- Knowledge of principles of drug safety, specifically case series analysis
- Basic understanding of industry regulations and compliance needs; knowledge of GVP Module IX preferred.
- Expert-level ability to search, analyze, interpret, and clearly present safety, scientific, and clinical data in written format
- Experience authoring complex aggregate safety reports and assessments
- Advanced-level skills in MS Outlook, Word, and Excel and Adobe Acrobat
- Excellent verbal and written communication skills; Strong English verbal and written communication skills
- Meticulous attention to detail and thorough completion of complicated tasks
- Expertise in pharmacology, epidemiology, biostatistics, and/or decision sciences preferred
- Expert-level skills in MS Excel and data manipulation in Excel
- Experience using GxP IT Systems; experience with Empirica signal platform preferred
- Must be strong independent worker and team player
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india ClinChoice Full timeKey Roles and Activities: Senior Surveillance Scientist:The Senior Surveillance Scientist will support the Signal Tracking Team and safety and quality systems, by performing activities such as, but not limited to: Attention to detail and ability to analyze data in a broader contextAbility to understand the nature of adverse drug reactions and complex...
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Safety Surveillance Scientist
7 days ago
India ClinChoice Full timeKey Roles and Activities: Senior Surveillance Scientist:The Senior Surveillance Scientist will support the Signal Tracking Team and safety and quality systems, by performing activities such as, but not limited to: Attention to detail and ability to analyze data in a broader contextAbility to understand the nature of adverse drug reactions and complex...
-
Safety Surveillance Scientist
7 days ago
India ClinChoice Full timeKey Roles and Activities : Senior Surveillance Scientist: The Senior Surveillance Scientist will support the Signal Tracking Team and safety and quality systems, by performing activities such as, but not limited to: Attention to detail and ability to analyze data in a broader context Ability to understand the nature of adverse drug reactions and complex...
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