Director, Signal Detection Scientist
Johnson & Johnson
Johnson & Johnson seeks a Director, Signal Detection Scientist to lead pharmacovigilance activities for complex pharmaceutical products. The role involves designing and executing post-marketing safety surveillance strategies, detecting emerging safety signals, and collaborating with cross-functional teams to evaluate and communicate findings to regulatory and medical stakeholders.
Responsibilities
- Lead systematic signal detection and validation activities for assigned innovative pharmaceutical products
- Prepare high-quality safety data reviews and communicate findings to medical officers and safety teams
- Develop and implement product-specific surveillance plans with internal and external partners
- Drive development of programmatic adverse event surveillance systems and methodologies
- Mentor Associate Director and develop training materials for safety personnel
Requirements
- Advanced degree in life sciences, pharmacy, medicine, or related field
- Extensive experience in pharmacovigilance, signal detection, or drug safety surveillance
- Proficiency with safety databases (FDA AEMS, WHO VigiBase, EMA EudraVigilance)
- Demonstrated expertise in statistical analysis and data mining methodologies
- Strong leadership experience managing scientific teams and cross-functional stakeholders
- Expert-level knowledge of regulatory safety requirements and post-marketing surveillance
- Role Lead signal detection activities within pharmacovigilance for complex, innovative pharmaceutical products, overseeing proactive safety monitoring and evaluation of emerging signals from post‑marketing data sources. Responsibilities develop and implement surveillance...Suggested
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