[Hiring] Manager Global Case Management Submissions @Otsuka Pharmaceutical Co., Ltd.

Role Description

As a member of the Drug Safety and Pharmacovigilance department, the Manager, PV Case Management (Submissions) is responsible for participating in the reporting of adverse event data in compliance with applicable global regulations. The role holder will ensure responsibility for all reports and submissions for the company’s medicinal and device products covering pre and post marketing activities.

• Support the reporting system of the GPV department, including managing the safety report schedule and reporting rules.
• Maintain compliant and core safety documents, planning all updates, scheduling, and carrying out all submissions within applicable regulatory timelines.
• Participate in the set-up and development of monitoring tools and maintenance of submissions workflow within the global safety database.
• Assist with the reconciliation of submission dates, site audit requests, and health authority responses.
• Assist in special projects as assigned.
• Maintain continuous knowledge and expertise of local and global requirements for safety reporting.
• Maintain a thorough knowledge and understanding of internal and business partner reporting rules.

Qualifications

• Must have sufficient experience and a demonstrated thorough knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance.
• Knowledge of the ARGUS Safety Database.
• Experience of case management and safety report submissions metrics.
• Knowledge and prior experience in case processing.
• Knowledge of the interworking’s of Global Pharmacovigilance organization is desired.
• Experience with managing vendors, partners, and/or CRO's preferred.

Requirements

• Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
• Strong communication and writing skills.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Ability to work under pressure in order to meet tight timelines.
• Able to work effectively in a matrix environment.
• Strong attention to detail along with the ability to problem solve.
• Excellent project management skills with the ability to align internal and external resources.
• Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.