Position Summary As a member of the Drug Safety and Pharmacovigilance department, the Manager, PV Case Management (Submissions) is responsible for participating in the reporting of adverse event data in compliance with applicable global regulations. The Manager, PV Case Management (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, PV Case Management (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, PV Case Management (Submissions) will assist with the reconciliation of submission dates, site audit requests, and health authority responses. The Manager, PV Case Management (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
Required:
Knowledge
- 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
Skills
- 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%) 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 $121,103.00 - Maximum $181,125.00, 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.
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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.
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