Senior Director, Safety Data Sciences
Listed on 2026-10-12
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Management
Regulatory Compliance Specialist
- Compensation: USD 206,500 - USD 393,000 - yearly
About Abb Vie
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at .
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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 pharmacovigilanceexpertisewith a forward-thinking, technology-enabled mindset. The Head of SDSwill advance modern, data-driven approaches to safety surveillance and signal management across the Abb Vie portfolio, including the thoughtful and responsible use of automation,analytics and AIhelping to drive Abb Vie'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, safetysurveillanceand aggregate safety data analysis across the Abb Vie portfolio, fostering accountability, scientific rigor,curiosity and mutual commitment.
Set the strategic direction for signal detection and surveillance, ensuring approaches are proactive,scalableand scientifically robust across development and marketed products.
Bring deepexpertisein diverse safety data sources, including clinical trial data, spontaneous adverse event reports, real-world data, literature, electronic healthrecordsand 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 approachesremaincompliant with global pharmacovigilance regulations and Abb Vie 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 thatmaintaincompliance and support high-quality safety decision-making.
Mentor and develop a diverse, multidisciplinary team, promoting professional growth, inclusive leadership, scientificexcellenceand 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, signalmanagementand aggregate data analysis, using data,technology and stakeholder feedback to improve quality,efficiency and consistency.
Qualifications- Advanced degree required (MD, PharmD, PhD) with
15+years of experience in Pharmacovigilance and Drug Safety– in industry/academia and comprehensive expertise in product lifecycle from first-in-human studies to post-marketing preferred.
At least8years of leadership experience managing global teams, with demonstrated success in driving impactful change preferred.
Strong ability to lead diverse teams and influence senior leadership across global patient safety, R&D and Abbvie, fostering a culture of innovation and excellence in safety science and safety data analysis and interpretation.
Excellent skills in relationship management and communication, underpinned by emotional…
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