Associate Director - Office of Safety Operations PV Systems (Remote)

Company Description

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

The Associate Director - Office of Safety Operations PV Systems this position supports the Safety Operations organization to achieve its mission of improving patient lives by delivering high quality, and timely adverse event management and through driving industry leading ICSR operations, ICSR standards and technology at AbbVie.

Responsibilities:

• Leads the development and consistent implementation of Abbvie's global clinical and postmarketing case management processes and technology
• Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies & training
• Implements new ICSR pharmacovigilance legislation into quality systems, metrics, and technical requirements
• Drives effective cross-functional collaboration with an emphasis on building strong business relationships with all relevant AbbVie stakeholders, including PPS, Commercial, GMA, RDQA, and Affiliates to establish and maintain harmonized ICSR processes
• Drives internal audits and external regulatory inspection activities; leads functional corrective and preventive action investigations
• Facilitates PPS' understanding of the changing regulatory environment as it impacts ICSR management, process, technology, and people
• An integral leader in the Office of Safety Operations team responsible for driving compliance and process business excellence for all ICSR PV activities
• Leverages global data and cross-functional insights to inform and optimize global ICSR operations including design of effective training approaches
• Leads cross-functional projects that support PPS' strategic objectives and drive process improvement initiatives with effective change management and rapid solutioning of unanticipated issues
• Drives identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and follow-up across stakeholders through resolution, prevention, and trending
• Presents results to senior, cross-functional AbbVie stakeholders. Participates in governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & Quality organizations
• Develops and directly manages a team of AbbVie staff to execute the above responsibilities, including coaching/mentoring for staff performance and development (up to 8 people)

Qualifications

Minimum Qualifications:

• Bachelor's Degree or equivalent in related science field.
• 5+ years pharmaceutical industry experience in pharmacovigilance and/or pharmaceutical business operations
• Demonstrated experience in direct line management required
• Highly Proficient in case processing processes, procedures, conventions

Preferred Qualifications:

• Global experience
• Advanced degree

Other Required Skills:

• Able to influence across multiple stakeholders and manage within a cross-functional matrix; seen as a collaborative leader at all levels of the organization
• Ability to proactively identify, rapidly assess, and effectively manage business and compliance risks
• Experienced in leading the development of training & quality documents (SOP / Guidelines / CAPAs)
• Significant experience leading cross-functional teams on complex projects. Proven success in results driven process management
• Strong influencing skills. Ability to manage complex issues and distill information.
• Demonstrates the willingness to make and accept unpopular decisions or take opposing positions.
• Demonstrates ability to establish clear directions. Utilizes creativity and original thinking throughout problem-solving processes.
• Advanced knowledge of global pharmacovigilance, including regulations (e.g. ICH, FDA, EMEA) and the affiliate operating model, with advanced understanding of related quality assurance systems including audits/inspections
• A leader in end-to-end ICSR process oversight (Clinical and Post-marketing)

Additional Information

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 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.
• 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 and until 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, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html