Senior Manager, Global Case Management, Case Processing - Hybrid

The Senior Manager of Case Processing is responsible for the management of ICSR case processing activities. This role leverages knowledge of global regulations, including US CFR, ICH and EU PV legislation, MedDRA and WHO-DD coding, to ensure high quality and compliance. This role will provide support to optimize case processing activities that are in accordance with company SOPs and regulatory requirements. Effective collaboration is required with key stakeholders, including, but not limited to GPV functional areas, Clinical Management, Data Management and Regulatory colleagues.

This role may be responsible for CWs/MSPs, who may be onsite or remote.

This role reports to the Global Case Management Case Processing Lead.

• Support the oversight of case processing activities and procedures, including the development and maintenance of appropriate oversight reports
• Responsible for compliance with company procedures and for ensuring case processing processes are optimized to ensure compliance with regulatory reporting timelines.
• Support the oversight of the case processing activities outsourced to PV Vendor
• Support the maintenance of the Case Processing Data Entry Conventions, Job Aid, and case management procedural/guidance documents.
• Support the creation, review, and completion of training material as appropriate
• Support the maintenance of training curricula for members of the Intake team and ensuring the training and mentoring of new personnel is completed.
• Responsible for the product/study configuration request process for the global safety database
• Collaborate with the Clinical Study Teams and Medical Safety Teams for assigned products in case processing-related activities, including support of clinical study start up activities
• Drive initiatives to improve quality of ICSRs and compliance, which could be team, functional or global in scope
• Collaborate with Safety Data Management to maintain the safety database to ensure ICSR quality and regulatory reporting is compliant
• Review case management sections of Pharmacovigilance Agreements (PVAs) and Safety Management Plans (SMPs)
• Participate in Regulatory Authority inspections and Company/Third Party audits, including serving as interviewee and/or responding to requests in a timely manner.
• Perform other tasks as assigned by the management of Global PV
• Escalate issues/risks appropriately to Case Processing Lead and/or Global Head of Case Management
• Serve as back-up to other Case Management team members, as needed

Qualifications Required:

• Bachelor's Degree minimum with license in Pharmacy, Nursing, or Life Science preferred
• Minimum 3 years of ICSR case processing experience
• Knowledge of US, ICH and EU PV and GCP regulations
• Experience working with vendors
• Experience working with Alliance Partners and Pharmacovigilance Agreements
• Experience with Argus safety database
• Working knowledge of MedDRA and WHO Drug dictionaries
• Experience with clinical case management
• Strong interpersonal and communication skills
• Detail oriented, with good organizational, prioritization, and time management skills
• Proficient in standard computer software (Word, Excel, and PowerPoint)
• Strong verbal and written skills

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.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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.

Minimum $131,153.00 - Maximum $187,550.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company 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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.