Senior Manager, Compliance & Business Management

Job Description

The Senior Manager, Global Pharmacovigilance (GPV) Compliance & Business Management (CBM), will support in the development and implementation of necessary processes for the management of routine compliance activities within the pharmacovigilance organization. This is a global role.  The job holder will also work collaboratively with other GPV groups, Affiliate PV Coordination Group (APVC), Global Quality Operations (GQO), the Global QPPV office and Regional Pharmacovigilance Heads to identify and meet various Global CBM objectives.

*At the discretion of the Global Head of CBM, it may be required to support activities within multi sub-function project teams as needed.

Key Responsibilities:

GPV Alliance Management (GPVAM)

• 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.

GPV Compliance & Analytics

• 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.

Additional Activities

• 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.

Job Scope (key facts & figures)

• 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.

Qualifications/ Experience Required

• 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