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Pharmacovigilance Scientist
Company | Sanofi |
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Location | Morristown, NJ, USA |
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Salary | $122250 – $176583.33 |
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Type | Full-Time |
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Degrees | |
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Experience Level | Mid Level, Senior |
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Requirements
- Working knowledge of drug safety and risk management including industry experience
- Understanding of drug development
- Basic knowledge of regulatory guidelines and medical coding
- Strong knowledge of pharmacovigilance practices including US and EU pharmacovigilance regulatory requirements
- Evaluation, interpretation, and synthetization of scientific data
- Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect, validate, and assess potential signals
- Ability to present and critically discuss safety data in both internal and external discussions
- Working knowledge of common data processing software and database systems
- Project management skills with demonstrated attention to detail, keeping in mind the broader picture
Responsibilities
- Manages proactive signal detection and safety management committee activities
- Coordinates and authors safety evaluations and responses to safety inquiries from internal or external stakeholders (i.e., Health Authorities) in collaboration with the safety team
- Drives end-to-end signal management process for assigned products in collaboration with the GSO and Pharmacoepidemiology
- Serves as a core member (coordinator) of the Safety Management Team, drives the agenda, produces the necessary data/outputs, prepares slide presentations, facilitates discussions & documents conclusions, and presents complete safety analysis
- Partners with the Safety Team to manage other safety related activities associated with new drug applications / regulatory filings, benefit-risk assessment and safety risk management and support activities related to risk minimization including development of Risk Management Plans
- Coordinates and oversees outsourced activities (i.e., signal detection reports, safety evaluation reports)
Preferred Qualifications
- Team player that performs effectively in a cross-functional collaborative environment
- Self–motivated, able to prioritize, plan effectively and independently
- Strategic, business oriented, and problem-solving mindset while keeping patients and customers at the forefront
- English proficiency in communication skills with scientific subject matter