As a member of the Drug Safety and Pharmacovigilance department, the Manager Global PV Operations - ICSR Submissions' is responsible for participating in the reporting of adverse event data in compliance with applicable global regulations. The Manager Global PV Operations - ICSR Submissions' will ensure responsibility for all the reports and submissions for the company's medicinal and device products covering pre and post marketing activities. The role holder will be a dedicated employee who will be supporting the reporting system of the GPV department which includes managing the safety report schedule and reporting rules. With the responsibility for maintaining compliant and core safety documents, planning all updates scheduling and carrying out all submissions within applicable regulatory timelines. The Manager Global PV Operations - ICSR Submissions' will participate in the set-up and development of monitoring tools and maintenance of submissions workflow within the global safety database to meet global regulatory reporting requirements. In addition Manager Global PV Operations - ICSR Submissions' will assist with the reconciliation of submission dates, site audit requests, and health authority responses. The Manager Global PV Operations - ICSR Submissions' will assist in special projects as assigned. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting. Must also maintain a thorough knowledge and understanding of internal and business partner reporting rules.
Key Job Responsibilities
Oversees the internal submissions process for all destinations including regulatory bodies, partners and internal departments
Tracks and monitors all ICSR timelines to ensure that submissions to regulatory agencies, business partners, and contract research organizations (CROs) are compliant with the regulatory requirements.
Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of major regulatory submissions.
Ensures the accuracy and completeness of electronic and hard copy regulatory submissions.
Provides support during interactions with regulatory agencies reviewing submission content.
Contributes to process improvement initiatives across the organization.
Assists with other regulatory activities and special projects as required.
Support the Manager PV Operations (Global ICSR Quality and Analytics) and team, escalating and investigating safety and non-compliance issues. In conjunction with the Manager PV Operations (Global ICSR Quality and Analytics) identify root causes for late ICSR submissions and implementation of appropriate corrective actions.
Actively manage the safety report scheduling and timelines.
Track and maintain compliance with regulatory timelines and submission requirements.
Work closely with the safety surveillance and case processing teams to achieve submission timelines
Assess impact of new regulations on the safety database reporting rules and oversees updates as appropriate
Participate in cross-functional meetings as the submissions lead.
Responsible for organizing and tracking safety information requests and responses
Maintaining a strong GPVP & GCP knowledge.
Generate and use established reports to monitor daily case workload and reports due, working with team members to identify potential bottle necks or resource gaps and coordinate work plans accordingly
Generate and use established reports to monitor reports worklist and additional worklist as needed.
Participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures
Follow company processes and guidelines for case management and closure activities, and adhere to company templates and guidelines for documentation and communications
Ensure compliance with corporate and departmental standard operating procedures
Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within PV Operations.
Assist in the preparation of ICSR health authority responses
May provide support and back-up to the Global PV workflow Associate
Perform other activities as directed by Drug Safety and Pharmacovigilance management
Provide management and oversight of E2B warnings and failures
Knowledge, Skills, Competencies, Education, and Experience
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
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).
Knows how/when to apply organizational policy or regulatory procedures to a variety of situations.
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
The ability to provide direction to a team, and to influence peers and team members appropriately preferred
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
Education and Related Experience
Degree preferred to be in Bachelor of Science or related healthcare degree however may be waived for relevant experience**
Minimum of 5 years drug safety experience required
Demonstrated proficiency in safety database functionality
Global Drug Safety Case processing experience*
*Safety experience is defined as actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance
Physical Demands and Work Environment
Travel (approximately 10%)
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.
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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