Senior Manager, Case Management Operations – Intake

Otsuka Pharmaceutical Co., Ltd. • Princeton, NJ

1d • $134,615 - $201,250

About The Position

Position Title: Senior Manager, Case Management Operations – Intake (Princeton, NJ) Responsibilities: Manage the day-to-day activities of the PV Operations department including Intake and Case Workflow and have direct oversight of the personnel assigned to perform their function specific activities. Leverage knowledge of CFR, ICH and EU PV legislation, MedDRA and WHO-DD coding, to ensure high quality and compliance. Effectively manage, distribute and assign workload to colleagues and contract resources in order to ensure effective resource utilization. Routinely collaborate with other departments including but not limited to Clinical, Regulatory, Quality and Data Management. Other responsibilities may include but are not limited to: Oversee the intake process including collection and processing of all ICSR information through email, paper, or electronic data capture tools. Assign appropriate product/project coverage through safety personnel assignments Monitor intake and workflow for compliance with procedures and reporting timelines. Escalate any issues to senior leadership. Ensure the intake and workflow procedures are aligned with pharmacovigilance agreements. Coordinate with ICSR and Aggregate Submission teams to ensure compliant submissions to all Regulatory bodies, collaborating companies and other recipients. Collaborate with PV Quality and Compliance and Safety Data Management to develop monitoring reports and procedures. Responsible to train and mentor new and existing personnel in line with Otsuka SOPs and global regulatory requirements. Maintain oversight of activities including but not limited to: reconciliation of adverse events; preparation and submission of product-specific reports in accordance with departmental and company guidelines; communication of monthly adverse event reports, product safety issues, and any related problems and concerns to CS team members and management in a timely manner; participation in clinical project start-up activities such as presentation for investigators meeting and interdepartmental training; and interaction and oversight of Contract Resource Organizations. Collaborate with Product Medical Directors, ensure appropriate decision making around case assessments. Ensure appropriate clinical safety support for global clinical and non-clinical projects, including those conducted in conjunction with affiliates, co-marketers, or Contract Research Organizations (CRO). Work with senior leadership to implement initiatives to improve workflow, process and compliance. Interact with Inspectors during Competent Authority Inspections (PV & GCP) and ensure timely response to requests. 20% of domestic travel for meetings. Requirements: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Dentistry, Nursing, or a related field in healthcare. Six (6) years of experience with pharmacovigilance. Six (6) years of experience using Argus safety database. Six (6) years of experience applying knowledge of MedDRA and WHO Drug dictionaries for coding. Four (4) years of experience with ICSR case processing. Four (4) years of experience working with case processing vendors. Four (4) years of experience collaborating with Alliance Partners. Four (4) years of experience ensuring compliance with safety agreements related to pharmacovigilance process. Compensation: $179,150 to $185,000 per year + benefits package (employer provided insurance, paid time off, 401(k), etc). Apply to: [email protected]. Otsuka Pharmaceutical Development & Commercialization, Inc. 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 $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline: This will be posted for a minimum of 5 business days. 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. Disclaimer: 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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. 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 Accommodation Request. Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities. 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. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. 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. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

Requirements

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Dentistry, Nursing, or a related field in healthcare.
• Six (6) years of experience with pharmacovigilance.
• Six (6) years of experience using Argus safety database.
• Six (6) years of experience applying knowledge of MedDRA and WHO Drug dictionaries for coding.
• Four (4) years of experience with ICSR case processing.
• Four (4) years of experience working with case processing vendors.
• Four (4) years of experience collaborating with Alliance Partners.
• Four (4) years of experience ensuring compliance with safety agreements related to pharmacovigilance process.

Responsibilities

• Manage the day-to-day activities of the PV Operations department including Intake and Case Workflow and have direct oversight of the personnel assigned to perform their function specific activities.
• Leverage knowledge of CFR, ICH and EU PV legislation, MedDRA and WHO-DD coding, to ensure high quality and compliance.
• Effectively manage, distribute and assign workload to colleagues and contract resources in order to ensure effective resource utilization.
• Routinely collaborate with other departments including but not limited to Clinical, Regulatory, Quality and Data Management.
• Oversee the intake process including collection and processing of all ICSR information through email, paper, or electronic data capture tools.
• Assign appropriate product/project coverage through safety personnel assignments
• Monitor intake and workflow for compliance with procedures and reporting timelines.
• Escalate any issues to senior leadership.
• Ensure the intake and workflow procedures are aligned with pharmacovigilance agreements.
• Coordinate with ICSR and Aggregate Submission teams to ensure compliant submissions to all Regulatory bodies, collaborating companies and other recipients.
• Collaborate with PV Quality and Compliance and Safety Data Management to develop monitoring reports and procedures.
• Responsible to train and mentor new and existing personnel in line with Otsuka SOPs and global regulatory requirements.
• Maintain oversight of activities including but not limited to: reconciliation of adverse events; preparation and submission of product-specific reports in accordance with departmental and company guidelines; communication of monthly adverse event reports, product safety issues, and any related problems and concerns to CS team members and management in a timely manner; participation in clinical project start-up activities such as presentation for investigators meeting and interdepartmental training; and interaction and oversight of Contract Resource Organizations.
• Collaborate with Product Medical Directors, ensure appropriate decision making around case assessments.
• Ensure appropriate clinical safety support for global clinical and non-clinical projects, including those conducted in conjunction with affiliates, co-marketers, or Contract Research Organizations (CRO).
• Work with senior leadership to implement initiatives to improve workflow, process and compliance.
• Interact with Inspectors during Competent Authority Inspections (PV & GCP) and ensure timely response to requests.

Benefits

• benefits package (employer provided insurance, paid time off, 401(k), etc)
• 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: Senior
• Number of Employees: 1,001-5,000 employees