Pharmacovigilance Scientist

Pharmacovigilance Scientist

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