Senior Scientific Director, Risk Management Architect, Office of Risk Management

vor 2 Wochen

Schaffhausen, Schweiz AbbVie AG Vollzeit
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

Purpose: Promotes risk minimization strategy and execution through the development and application of a structured, iterative, end-to-end lifecycle risk management framework.

This role is location-independent and can be performed from anywhere within Europe.

Responsibilities:

  1. Serves as the subject matter expert on Risk Minimization Measures tool development, implementation, and effectiveness evaluation.
  2. Advises Product Safety Teams (PST) and Affiliates on risk minimization measures to support product development programs, new marketing applications, and marketed products.
  3. Advises the PST Leads and Affiliates on additional risk minimization measures (RMM) tools and implementation.
  4. Leads the development of the core implementation strategy and core effectiveness evaluation plan in collaboration with the PST and Epidemiology.
  5. Selects and manages vendors to develop additional RMM when needed.
  6. Ensures appropriate user testing of risk minimization materials in collaboration with the Office of Health Literacy.
  7. Advises local affiliate for additional risk minimization country distribution plans when required.
  8. Supports affiliate inspection and audits with respect to additional RMM.
  9. Assess and recommend industry-leading approaches to best implement additional RMM including the use of digital health tools.
  10. Drive the development and maintenance of an end-to-end lifecycle risk management framework. This includes education, best practices, and standards for risk management processes and activities.
  11. A champion for building and managing risk management literacy across PSEQ.

Qualifications

Qualifications/Experience:

  1. Health professional degree (MD, PharmD, RPh, RN or related degree) or master’s degree in lifesciences or related field.
  2. Minimum 10+ years experience in patient safety risk management or related experience for pharma or a regulatory agency.

Desired Skills/Experience:

  1. Trained or experienced in implementation science, program evaluation, methodological approaches, or outcomes research.
  2. Knowledge of risk management regulations, guidelines or equivalent.
  3. Demonstrated experience in global drug safety risk management planning activities and generating RMPs.
  4. Ability to lead teams and projects across a wide variety of stakeholders.
  5. Demonstrated strength in analytical skills and attention to detail.
  6. Demonstrated strength in oral/written communication.
  7. Excellent mentoring, interpersonal communication (oral, written), negotiation, and influencing skills.
  8. Aptitude in decision-making and problem-solving in a complex environment while influencing multi-functional teams across disciplines, cultures, third-parties, and geographic locations.
  9. Ability to craft compelling business cases and effectively champion new ideas.
  10. Ability to effectively frame complex issues for decision-makers, and peers and facilitates lessons learned.

Additional Information

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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