Associate Director, Safety Operations Portfolio
Allergan, Irvine, CA, United States
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. The role leads the SOPROL (Safety Operations Product Leadership) team and collaborates with Therapeutic Area Heads as well as senior scientific leaders across Global Patient Safety, Global Medical Affairs, Clinical Development and Regulatory Affairs. The position ensures accurate, high‑quality, timely Safety Operations scientific input and support are provided to PSTs across assets (development and on‑market) from discovery to end of life, overseeing 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, supporting PST responsibilities and deliverables (e.g., regulatory responses, submissions, launches, audits/inspections, clinical trial protocol reviews).
Oversee 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 from an enterprise and international perspective and provide direction to SOPROL team members to enhance quality.
Interpret and implement global regulations related to clinical trial and pharmacovigilance supporting all patient safety activities. Collaborate with the QPPV Office in applying international regulatory requirements.
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 scientific recommendations to optimize safety strategies for high‑profile assets.
Maintain a comprehensive understanding of AbbVie’s pipeline and commercial priorities and apply this understanding to ICSR forecasting and broader Safety Operations business planning.
Proactively prepare GPS leadership communications to share crucial insights from ICSR data across key assets, strengthening safety understanding, narratives and actions.
Mange 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, supporting high‑quality scientific decision‑making and agility in cross‑functional partnerships.
Represent VP Safety Operations in senior leadership scientific discussions on assets and 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).
Manage audit and inspection preparedness, supporting PSTs and preparing Portfolio Leads and Product Managers for SME direct participation in front and back rooms.
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 experience working in the healthcare industry with a strong understanding of the drug development process.
A previous pharmacovigilance leadership role preferred.
Minimum 3 years of clinical development experience.
4 years of pharmacovigilance experience required.
Demonstrated ability to collaborate with internal and external stakeholders such as affiliates, health authorities, and third‑party vendors preferred.
Significant experience leading cross‑functional teams on complex projects required.
Significant experience in directly leading and driving major change initiatives within a team.
Strong leadership presence and 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.
Compensation and Benefits
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.
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 and until paid and may be modified at the company’s sole and absolute discretion, consistent with applicable law.
Equal Opportunity Employment 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: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation: https://www.abbvie.com/join-us/reasonable-accommodations.html
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Responsibilities
Develop, communicate, and implement the strategy for providing scientific expertise and support across all Safety Operations activities for assets, supporting PST responsibilities and deliverables (e.g., regulatory responses, submissions, launches, audits/inspections, clinical trial protocol reviews).
Oversee 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 from an enterprise and international perspective and provide direction to SOPROL team members to enhance quality.
Interpret and implement global regulations related to clinical trial and pharmacovigilance supporting all patient safety activities. Collaborate with the QPPV Office in applying international regulatory requirements.
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 scientific recommendations to optimize safety strategies for high‑profile assets.
Maintain a comprehensive understanding of AbbVie’s pipeline and commercial priorities and apply this understanding to ICSR forecasting and broader Safety Operations business planning.
Proactively prepare GPS leadership communications to share crucial insights from ICSR data across key assets, strengthening safety understanding, narratives and actions.
Mange 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, supporting high‑quality scientific decision‑making and agility in cross‑functional partnerships.
Represent VP Safety Operations in senior leadership scientific discussions on assets and 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).
Manage audit and inspection preparedness, supporting PSTs and preparing Portfolio Leads and Product Managers for SME direct participation in front and back rooms.
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 experience working in the healthcare industry with a strong understanding of the drug development process.
A previous pharmacovigilance leadership role preferred.
Minimum 3 years of clinical development experience.
4 years of pharmacovigilance experience required.
Demonstrated ability to collaborate with internal and external stakeholders such as affiliates, health authorities, and third‑party vendors preferred.
Significant experience leading cross‑functional teams on complex projects required.
Significant experience in directly leading and driving major change initiatives within a team.
Strong leadership presence and 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.
Compensation and Benefits
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.
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 and until paid and may be modified at the company’s sole and absolute discretion, consistent with applicable law.
Equal Opportunity Employment 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: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation: https://www.abbvie.com/join-us/reasonable-accommodations.html
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