Senior Director, Safety Data Sciences
AbbVie
Job Description
Job Description
Company Description
About AbbVie
AbbVie'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 AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionPurpose:
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.
- 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 least 8 years 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 intelligence
Thorough understanding of global PV regulations, risk management, labelling and the interconnectedness of safety science, real world data and drug development.
Strong and seasoned leader able to lead, motivate and inspire a diverse and team located across multiple geographical locations.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit -us/equal-employment-opportunity-employer.html
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