Senior Manager, Case Management

Key Job Responsibilities

The Senior Manager PV Operations of Global Case Processing manages the day-to-day activities of the PV Operations department including Intake and Case Workflow and has 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 deparments 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.
  • Clinical project start-up activities such as presentation for Investigators meeting and interdepartmental training.
  • Interactions and oversight with 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 and quality

responses to inspection requests

• Perform other tasks as assigned by the management of global PV

Knowledge, Skills, Competencies, Education, and Experience

Required:

• Extensive knowledge of US, ICH and EU PV and GCP regulations
• Minimum 2-4 years of ICSR case processing experience
• Minimum 4-6 years of PV experience
• Excellent strategic decision-making and analytical skills
• Strong verbal and writing skills
• Experience managing vendors
• Experience with clinical case management
• Bachelor’s Degree minimum.

Preferred:

• PharmD., pharmacy or nursing degree is preferred
• Regulatory writing experience
• Experience in aggregate report writing and development
• Experience with Pharmacovigilance Agreements, preferred
• Strong technical experience with Argus database, preferred

Physical Demands and Work Environment

Travel (approximately 20%)

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, patie