Senior Manager, Compliance & Business Management

Otsuka Pharmaceutical Co., Ltd. • Princeton, NJ

35d

About The Position

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.

Requirements

• Bachelor's degree
• Expertise in Good Pharmacovigilance Practice (GPvP)
• Minimum 2 years PV Compliance or Quality Management experience in the pharmaceutical industry.
• Microsoft proficient
• 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.

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.
• 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.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees