Job Description

Johnson & Johnson seeks an Associate Director to lead signal detection and safety surveillance strategies for pharmaceutical products. The role involves identifying and assessing safety signals from post-marketing data, developing surveillance plans, and implementing novel analytical methodologies across multiple data sources.

Responsibilities

• Conduct systematic review and validation of safety signals and adverse event trends from internal and regulatory databases
• Develop and implement product-specific surveillance plans with cross-functional safety teams
• Generate summary analysis reports and recommendations for signal evaluation with minimal guidance
• Pilot and evaluate novel computer-assisted tools and methodologies for safety data analysis
• Communicate signal detection findings through routine reporting and participation in safety meetings

Requirements

• Bachelor's degree minimum, preferably healthcare-related; advanced degree preferred
• Minimum 3 years pharmacovigilance or drug safety industry experience
• Knowledge of global regulatory requirements for adverse event processing and reporting
• Proficiency with single case assessment, aggregate data reviews, and safety issue evaluation
• Strong data manipulation skills in MS Excel; SAS JMP or similar platforms preferred
• Excellent verbal and written communication with strong analytical abilities
• Project leadership capability and ability to present complex data clearly

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