Associate Director, Safety Operations Portfolio
BioSpace, North Chicago, IL, United States
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 www.abbvie.com. 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
Develop, communicate and implement the strategy for providing scientific expertise and support across all Safety Operations activities for assets, in support of PST responsibilities and deliverables, which includes but is not limited to regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews, etc. 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). Review scientific content through an enterprise and international lens and provide direction to the SOPROL team members to enhance quality of scientific input. Interpret and implement global regulations related to clinical trial and pharmacovigilance supporting all patient safety activities; collaborate with the QPPV Office in the application of international regulatory requirements in Safety Operations activities. Build 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; provide Safety Operations scientific recommendations to help optimize safety strategies for high‑profile assets. Maintain a comprehensive understanding of the strategic direction of AbbVie’s pipeline and commercial priorities; apply understanding in making recommendations on ICSR forecasting and broader Safety Operations business planning. Proactively prepare GPS leadership communications to share crucial insights from ICSR data across key assets, that further strengthen safety understanding, narratives and actions. Manage talent development and utilization of SOPROL Portfolio Leads and Product Managers; engage, inspire, coach and mentor the team. Partner 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. Manage audit and inspection preparedness, in support of PSTs; prepare Portfolio Leads and Product Managers for product SME direct participation in front and back rooms. Represent VP Safety Operations in senior leadership scientific discussions on assets; serve on GPS scientific governance bodies as needed. Perform SOPROL responsibilities for sensitive or confidential assets (e.g., related to acquisition deals and company partnerships). Qualifications
Minimum: Bachelor’s degree with a related health sciences background; licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD or advanced degree). At least 6 years of experience working in the healthcare industry and a strong understanding of the drug development process. Previous Pharmacovigilance leadership role preferred; 4 years of pharmacovigilance experience required. Significant experience leading cross‑functional teams on complex projects; demonstrated ability in directly leading and driving major change initiatives within a team. Strong leadership presence and a demonstrated ability to courageously challenge the status quo and influence others; experience working directly with and influencing senior management. High emotional intelligence, strong relationship management and communication skills. Understanding of the connections between regulations and science for the benefit of drug safety. Additional Information
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 this posting 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 short‑term incentive programs. 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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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 www.abbvie.com. 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
Develop, communicate and implement the strategy for providing scientific expertise and support across all Safety Operations activities for assets, in support of PST responsibilities and deliverables, which includes but is not limited to regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews, etc. 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). Review scientific content through an enterprise and international lens and provide direction to the SOPROL team members to enhance quality of scientific input. Interpret and implement global regulations related to clinical trial and pharmacovigilance supporting all patient safety activities; collaborate with the QPPV Office in the application of international regulatory requirements in Safety Operations activities. Build 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; provide Safety Operations scientific recommendations to help optimize safety strategies for high‑profile assets. Maintain a comprehensive understanding of the strategic direction of AbbVie’s pipeline and commercial priorities; apply understanding in making recommendations on ICSR forecasting and broader Safety Operations business planning. Proactively prepare GPS leadership communications to share crucial insights from ICSR data across key assets, that further strengthen safety understanding, narratives and actions. Manage talent development and utilization of SOPROL Portfolio Leads and Product Managers; engage, inspire, coach and mentor the team. Partner 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. Manage audit and inspection preparedness, in support of PSTs; prepare Portfolio Leads and Product Managers for product SME direct participation in front and back rooms. Represent VP Safety Operations in senior leadership scientific discussions on assets; serve on GPS scientific governance bodies as needed. Perform SOPROL responsibilities for sensitive or confidential assets (e.g., related to acquisition deals and company partnerships). Qualifications
Minimum: Bachelor’s degree with a related health sciences background; licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD or advanced degree). At least 6 years of experience working in the healthcare industry and a strong understanding of the drug development process. Previous Pharmacovigilance leadership role preferred; 4 years of pharmacovigilance experience required. Significant experience leading cross‑functional teams on complex projects; demonstrated ability in directly leading and driving major change initiatives within a team. Strong leadership presence and a demonstrated ability to courageously challenge the status quo and influence others; experience working directly with and influencing senior management. High emotional intelligence, strong relationship management and communication skills. Understanding of the connections between regulations and science for the benefit of drug safety. Additional Information
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 this posting 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 short‑term incentive programs. 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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