Purpose:
The Head of Safety Data Sciences provides strategic, scientific and operational leadership for the Safety Data Sciences function within Global Patient Safety. The role is designed for an accomplished signal detection and surveillance leader who combines deep pharmacovigilance expertise with a forward-thinking, technology-enabled mindset. The Head of SDS will advance modern, data-driven approaches to safety surveillance and signal management across the AbbVie portfolio, including the thoughtful and responsible use of automation, analytics and AI helping to drive AbbVie's mission to deliver compassionate and innovative treatments that enhance patients' quality of life.
Key Responsibilities:
Lead a global team of 40+ physicians, pharmacists and healthcare professionals accountable for signal detection, safety surveillance and aggregate safety data analysis across the AbbVie portfolio, fostering accountability, scientific rigor, curiosity and mutual commitment.
Set the strategic direction for signal detection and surveillance, ensuring approaches are proactive, scalable and scientifically robust across development and marketed products.
Bring deep expertise in diverse safety data sources, including clinical trial data, spontaneous adverse event reports, real-world data, literature, electronic health records and preclinical findings, and guide the team in integrating these sources to identify, evaluate and contextualize potential signals.
Champion forward-thinking methods for the analysis and interpretation of safety data, including exploratory analytics, advanced visualization, automation and AI-enabled capabilities, while ensuring that all approaches remain compliant with global pharmacovigilance regulations and AbbVie guardrails.
Continuously advance signal management capabilities through fit-for-purpose tools, technology, training and mentorship, building organizational confidence in responsible AI and digital transformation in safety surveillance.
Ensure strong understanding of fast-evolving global PV regulations and translate external expectations into effective internal processes, procedures and standards that maintain compliance and support high-quality safety decision-making.
Mentor and develop a diverse, multidisciplinary team, promoting professional growth, inclusive leadership, scientific excellence and a mindset of innovation.
Partner with TA Heads to ensure appropriate cross-functional Safety Data Sciences support for each therapeutic area within Global Patient Safety.
Partner with the Safety Data Architect team to deliver seamless, optimized and technology-enabled signal management approaches for development products, including aligned strategies, clear communication channels for ongoing monitoring and protocols for safety issue escalation and resolution.
Lead the SDS team in the development and execution of major pharmacovigilance deliverables, including safety assessments, regulatory responses, risk management plans, PSURs and PADERs, in alignment with TA safety physician strategy.
Drive continuous process improvement across surveillance, signal management and aggregate data analysis, using data, technology and stakeholder feedback to improve quality, efficiency and consistency.