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

Director, Office of Safety Operations (Global) – Flexible location

Reporting to the Senior Director of Safety OperationsFlexible on locations globallyCompetitive salary, LTI’s, Bonus and benefits (Country variations may apply)

 

Objective

This position supports the Safety Operations organisation 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.

 

Highlighted responsibilities

Drives the development and consistent implementation of AbbVie’s global clinical and post-marketing case management processes and technology.Designs compliant and efficient ICSR pharmacovigilance processes, technologies & trainingDrives implements of new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements & training.Leads 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.Acts as a functional leader for internal audits and external regulatory inspection activities; leads functional corrective and preventive action investigations.Leads 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 Leadership team.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.Ensures proactive identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and follow-up across stakeholders through resolution, prevention, and trendingDevelops and directly manages a team of AbbVie staff to execute the above responsibilities, including coaching/mentoring for staff performance and development (up to 15 people)
Qualifications

Qualifications & Experience

Bachelor’s Degree or equivalent in related science field. Advanced degree preferredPharmaceutical industry experience; including pharmacovigilance and/or business operations experience.Previous direct line management experience, skilled at managing personnel of varying experienceGlobal experience requiredSignificant leadership experience to manage multifunctional responsibilities, influence and be identified as a collaborative partner at all levels of the organizationAbility to proactively identify, rapidly assess, and effectively manage & mitigate business and compliance risksIdentified strengths in team building and relationship managementSignificant experience leading cross-functional teams on complex projects. Proven success in results driven process management   Superior influencing skills. Ability to manage complex issues and distill information.Demonstrates the willingness to make and accept unpopular decisions or take opposing positions.
Additional Information

AbbVie 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.