Senior Manager, Compliance & Business Management

* Responsible for supporting the development and maintenance of Pharmacovigilance Agreements (PVAs).
* Responsible for ensuring compliance with global, local and regional PV regulations and policies/procedures and take corrective and/or preventive actions, when needed and as applicable to PVAs.
* Support PV audits/inspections and assist in developing CAPAs in response to findings/observations in relation to PVAs and compliance.
* Manage routine compliance metrics in pharmacovigilance activities related to PVAs.
* Perform impact analysis regarding PV compliance strategies and work instructions including input into PVAs.
* Participate in the root cause analysis, identification and investigation of non-adherence (deviations) to PV requirements in accordance with the PVA or PVA processes.
* Facilitate round table reviews/comments resolution meetings as needed.
* Support other GPVAM activities as applicable.
* Responsible for compiling compliance metrics according to local and regional PV regulations and Otsuka's policies/procedures and to request implementation of corrective and/or preventive actions, when needed.
* Ensure implementation of relevant updates to PV regulations to the impacted tasks in scope of the role, within the required timeline.
* Develop and implement metrics and dashboards to ensure regulatory requirements for PV are compiled and risks are minimized.
* Facilitate early detection of potential compliance through trend analyses and subsequent timely reporting to the relevant regional stakeholders (e.g. in Europe the EU-QPPV has to be included).
* Responsible for driving automation and innovation in compliance monitoring.
* Attend Global / Regional meetings as required.
* Present compliance metrics at Global Meetings.
* Contribute to maintenance of PV System Master File as required.
* May be assigned to lead or assist with special projects or process development.
* May perform any other duties as needed.
* Travel as applicable
* Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance.
* Solid background and experience in pharmaceutical quality system management (GxP).
* Experience with participation in PV audits in the pharmaceutical industry.
* Strong project management, interpersonal, communication and presentation skills.
* Ability to accomplish objectives through influence in a matrix organization.
* Strong computer skills with Word, Excel, PowerPoint, and Outlook.
* Bachelor's degree
* Expertise in Good Pharmacovigilance Practice (GPvP)
* Technical skills & experience
* Minimum 2 years PV Compliance or Quality Management experience in the pharmaceutical industry.
* Microsoft proficient
** Competencies*
* ** Accountability for Results
- ** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.  
** Strategic Thinking & Problem Solving
- ** Make decisions considering the long-term impact to customers, patients, employees, and the business.  
** Patient & Customer Centricity
- ** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.  
** Impactful Communication
- ** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.  
** Respectful Collaboration
- ** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.  
** Empowered Development
- ** Play an active role in professional development as a business imperative.

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations.

In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
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