Purpose:

This position manages a team of Portfolio Leads and Product Leads who are responsible for Safety Operations-related scientific activities, input and expertise across assets in all therapeutic areas. This position leads the SOPROL (Safety Operations Product Leadership) team. This role works with Therapeutic Area Heads and senior/executive scientific leaders across Global Patient Safety(GPS), Global Medical Affairs, Clinical Development and Regulatory Affairs. The role is responsible for ensuring that accurate, high-quality and timely Safety Operations scientific input and support are provided to PSTs across assets (development and on-market) from discovery to end of life. Safety Operations oversees the intake, processing, and reporting of patient safety information.

Responsibilities:

• Develops, communicates and implements the strategy for providing scientific expertise and support across all Safety Operations activities for assets, in support of PST responsibilities and deliverables. This includes but not limited to regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews, etc.

• Responsible for oversight of the accuracy, quality and timeliness of all scientific input for the end-to-end spectrum of Safety Operations activities for pharmaceutical and device assets (in development and on-market). Reviews scientific content through an enterprise and international lens. Provides direction to SOPROL team members to enhance quality of scientific input.

• Interprets and implements global regulations related to clinical trial and pharmacovigilance supporting all patient safety activities. Collaborates with the QPPV Office in the application of international regulatory requirements in Safety Operations activities.

• Builds strong collaborative relationships with PST Therapeutic Area leadership and Group Medical Directors, as well as senior leaders in Epidemiology and Medical Aesthetics & Device Safety, Clinical Trial Safety & Insights. Provides Safety Operations scientific recommendations to help optimize safety strategies for high-profile assets.

• Maintains a comprehensive understanding of the strategic direction of AbbVie’s pipeline and commercial priorities. Applies understanding in making recommendations on ICSR forecasting and broader Safety Operations business planning.

• Proactively prepares GPS leadership communications to share crucial insights from ICSR data across key assets, that further strengthen safety understanding, narratives and actions.

• Manges talent development and utilization of SOPROL Portfolio Leads and Product Managers. Engages, inspires, coaches and mentors team.

• Partners with senior scientific leadership cross-functionally (Global Medical Affairs, Regulatory Affairs, Clinical Development, etc.) to advance the priorities of SOPROL and the broader Safety Operations team, with the goal of supporting high quality scientific decision-making and agility in cross-functional partnerships.

• Manages audit and inspection preparedness, in support of PSTs. Prepares Portfolio Leads and Product Managers for product SME direct participation in front and back rooms.

• Represents VP Safety Operations in senior leadership scientific discussions on assets. Serves on GPS scientific governance bodies as needed

• Performs SOPROL responsibilities for sensitive or confidential assets (e.g. related to acquisition deals and company partnerships)