Associate Director, Safety Operations Portfolio
AbbVie
2 months ago
Remote friendly (Irvine, CA)
United States
Operations
Purpose:
- Manages a team of Portfolio Leads and Product Leads responsible for Safety Operations-related scientific activities, input, and expertise across assets in all therapeutic areas.
- Leads the SOPROL (Safety Operations Product Leadership) team.
- Ensures 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 (including intake, processing, and reporting of patient safety information).
Responsibilities:
- Develops, communicates, and implements the strategy for providing scientific expertise and support across Safety Operations activities (e.g., regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews).
- Oversees the accuracy, quality, and timeliness of all Safety Operations scientific input for pharmaceutical and device assets (in development and on-market); reviews content with an enterprise and international lens; directs SOPROL team to enhance quality.
- Interprets and implements global clinical trial and pharmacovigilance regulations supporting patient safety activities; collaborates with the QPPV Office.
- Builds collaborative relationships with PST Therapeutic Area leadership, Group Medical Directors, and senior leaders (Epidemiology, Medical Aesthetics & Device Safety, Clinical Trial Safety & Insights); provides scientific recommendations to optimize safety strategies for high-profile assets.
- Maintains understanding of pipeline and commercial priorities; applies insights to ICSR forecasting and Safety Operations business planning.
- Prepares GPS leadership communications sharing critical ICSR insights across key assets.
- Manages talent development and utilization of SOPROL Portfolio Leads and Product Managers (engages, inspires, coaches, mentors).
- Partners cross-functionally (Global Medical Affairs, Regulatory Affairs, Clinical Development, etc.) to advance SOPROL priorities and support agile, high-quality scientific decision-making.
- Manages audit/inspection preparedness; prepares Portfolio Leads and Product Managers for product SME participation in front and back rooms.
- Represents VP Safety Operations in senior leadership scientific discussions; serves on GPS scientific governance bodies as needed.
- Performs SOPROL responsibilities for sensitive/confidential assets (e.g., acquisition deals and partnerships).
Qualifications:
Minimum:
- Bachelor’s degree with related health sciences background; licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD, or advanced degree preferred).
- At least 6 years’ healthcare industry experience with strong understanding of the drug development process.
- Minimum 3 years of clinical development experience.
- 4 years of pharmacovigilance experience (required).
Preferred:
- Previous Pharmacovigilance leadership role.
- Demonstrated ability to collaborate with internal/external stakeholders (Affiliates, Health Authorities, third-party vendors).
- Significant experience leading cross-functional teams on complex projects.
- Significant experience leading and driving major change initiatives.
- Strong leadership presence; ability to challenge the status quo and influence senior management.
- High emotional intelligence; strong relationship management and communication skills.
- Understanding of connections between regulations and science for drug safety.
Benefits (as stated):
- Comprehensive benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligibility to participate in short-term incentive programs.
Application instructions:
- None stated in the job description body.
- Manages a team of Portfolio Leads and Product Leads responsible for Safety Operations-related scientific activities, input, and expertise across assets in all therapeutic areas.
- Leads the SOPROL (Safety Operations Product Leadership) team.
- Ensures 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 (including intake, processing, and reporting of patient safety information).
Responsibilities:
- Develops, communicates, and implements the strategy for providing scientific expertise and support across Safety Operations activities (e.g., regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews).
- Oversees the accuracy, quality, and timeliness of all Safety Operations scientific input for pharmaceutical and device assets (in development and on-market); reviews content with an enterprise and international lens; directs SOPROL team to enhance quality.
- Interprets and implements global clinical trial and pharmacovigilance regulations supporting patient safety activities; collaborates with the QPPV Office.
- Builds collaborative relationships with PST Therapeutic Area leadership, Group Medical Directors, and senior leaders (Epidemiology, Medical Aesthetics & Device Safety, Clinical Trial Safety & Insights); provides scientific recommendations to optimize safety strategies for high-profile assets.
- Maintains understanding of pipeline and commercial priorities; applies insights to ICSR forecasting and Safety Operations business planning.
- Prepares GPS leadership communications sharing critical ICSR insights across key assets.
- Manages talent development and utilization of SOPROL Portfolio Leads and Product Managers (engages, inspires, coaches, mentors).
- Partners cross-functionally (Global Medical Affairs, Regulatory Affairs, Clinical Development, etc.) to advance SOPROL priorities and support agile, high-quality scientific decision-making.
- Manages audit/inspection preparedness; prepares Portfolio Leads and Product Managers for product SME participation in front and back rooms.
- Represents VP Safety Operations in senior leadership scientific discussions; serves on GPS scientific governance bodies as needed.
- Performs SOPROL responsibilities for sensitive/confidential assets (e.g., acquisition deals and partnerships).
Qualifications:
Minimum:
- Bachelor’s degree with related health sciences background; licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD, or advanced degree preferred).
- At least 6 years’ healthcare industry experience with strong understanding of the drug development process.
- Minimum 3 years of clinical development experience.
- 4 years of pharmacovigilance experience (required).
Preferred:
- Previous Pharmacovigilance leadership role.
- Demonstrated ability to collaborate with internal/external stakeholders (Affiliates, Health Authorities, third-party vendors).
- Significant experience leading cross-functional teams on complex projects.
- Significant experience leading and driving major change initiatives.
- Strong leadership presence; ability to challenge the status quo and influence senior management.
- High emotional intelligence; strong relationship management and communication skills.
- Understanding of connections between regulations and science for drug safety.
Benefits (as stated):
- Comprehensive benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligibility to participate in short-term incentive programs.
Application instructions:
- None stated in the job description body.