Manager Global Case Management Submissions

Otsuka Pharmaceutical Co., Ltd.

10d•$121,103 - $181,125

About The Position

As a member of the Drug Safety and Pharmacovigilance department, the Manager, PV Case Management (Submissions) participates in reporting adverse event data in compliance with applicable global regulations. The role is responsible for reports and submissions for the company’s medicinal and device products across pre- and post-marketing activities, and supports the GPV department’s reporting system, safety report schedules, and reporting rules. The manager maintains compliant core safety documents, plans and schedules updates, and completes submissions within applicable regulatory timelines. The position participates in setting up and developing monitoring tools and maintaining submission workflows in the global safety database to meet global reporting requirements. It also assists with reconciling submission dates, site audit requests, and health authority responses, and supports special projects as assigned. The role requires continuously maintaining expertise in local and global safety reporting requirements and a thorough understanding of internal and business partner reporting rules.

Requirements

Thorough knowledge and understanding of global safety reporting regulations and guidelines, including FDA, ICH, and EU pharmacovigilance regulations and requirements.
Knowledge of the ARGUS Safety Database.
Experience with case management and safety report submission metrics.
Knowledge of and prior experience in case processing.
Strong technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
Strong communication and writing skills.
Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to apply organizational policies or regulatory procedures appropriately in varied situations.
Ability to work under pressure and meet tight timelines.
Ability to work effectively in a matrix environment.
Strong attention to detail and problem-solving ability.
Excellent project management skills and ability to align internal and external resources.
Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations.
Minimum of 5 years of drug safety experience.
Demonstrated proficiency in safety database functionality.
Global drug safety case-processing experience.
Safety experience must include actual experience processing AE/SAE reports, generating narratives and queries, working within safety databases, and experience with regulatory submissions.
Relevant experience may be from pharmaceutical, biotechnology, or CRO industries, including related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance.

Nice To Haves

A degree in Bachelor of Science or a related healthcare field is preferred; the degree requirement may be waived for relevant experience.
Knowledge of the workings of a global Pharmacovigilance organization.
Experience managing vendors, partners, and/or CROs.
Ability to provide direction to a team and appropriately influence peers and team members.

Responsibilities

Oversee the internal submissions process for all destinations, including regulatory bodies, partners, and internal departments.
Track and monitor ICSR timelines to ensure submissions to regulatory agencies, business partners, and CROs meet regulatory requirements.
Identify or anticipate roadblocks and help develop solutions supporting the scheduling and timelines of major regulatory submissions.
Ensure electronic and hard-copy regulatory submissions are accurate and complete.
Support interactions with regulatory agencies reviewing submission content.
Contribute to organization-wide process improvement initiatives.
Assist with other regulatory activities and special projects as required.
Support the Manager PV Operations (Global ICSR Quality and Analytics) and team by escalating and investigating safety and non-compliance issues.
Work with the Manager PV Operations (Global ICSR Quality and Analytics) to identify root causes of late ICSR submissions and implement appropriate corrective actions.
Actively manage safety report scheduling and timelines.
Track and maintain compliance with regulatory timelines and submission requirements.
Work closely with safety surveillance and case processing teams to achieve submission timelines.
Assess the impact of new regulations on safety database reporting rules and oversee updates as appropriate.
Participate in cross-functional meetings as the submissions lead.
Organize and track safety information requests and responses.
Generate and use established reports to monitor daily case workloads and reports due; work with team members to identify potential bottlenecks or resource gaps and coordinate work plans.
Generate and use established reports to monitor report worklists and additional worklists as needed.
Participate in setting up and maintaining adverse event workflow processes, department policies, and standard operating procedures.
Follow company case-management and closure processes and guidelines, and adhere to documentation and communication templates and guidelines.
Ensure compliance with corporate and departmental standard operating procedures.
Contribute to standardized practices and procedures, and to measures of productivity and performance within PV Operations.
Assist in preparing ICSR health authority responses.
Provide support and backup to the Global PV workflow Associate as needed.
Perform other activities as directed by Drug Safety and Pharmacovigilance management.
Provide management and oversight of E2B warnings and failures.