Senior Manager, GPV Aggregate Report & RMP Operations

Job Summary

Senior Manager, GPV Aggregate Report & RMP Operations

Apply knowledge and expertise in the area of aggregate reports and risk management plans. Lead project management activities for Aggregate Reports, Risk Management Plans; PV-related HA request, Safety Governance; and other relevant projects.

Job Description

• Drives development and maintenance of a center of excellence for Pharmacovigilance Aggregate Reporting and Risk Management Deliverables
• Reports to the Global Lead of Aggregate Report & RMP Operations
• Contributes to the project management for production of Aggregate Safety Reports (i.e. PSURs/PBRER, PADER, DSURs, SUSAR), Risk Management Plans (RMPs), PV-related Health Authority responses. Facilitate production activities, including data procurement across GxP functions, creation and management of workflows in electronic document management system, and provision of technical guidance to authors and contributors, aggregate reports and risk management plans & pv-related HA responses
• Contributes to the development and maintenance of efficient and robust procedures to drive quality, timeliness and compliance with regulations
• Lead tasks and projects to ensure all activities are completed on time and meet quality standards. Builds a positive, collaborative team environment by leading by example, providing training and mentoring for team members as well as outside of GPV
• Interface with other functional groups, such as Regulatory Affairs, Clinical Management/Clinical Development or other business units as needed
• Participates in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies and/or other projects
• Support audits and inspections in areas of document requests, interviews, and any other support activities
• Train and mentor new team members

Operational responsibilities for Global PV Safety Governance:

• Facilitate safety governance meetings (procure data and presentation materials, send reminders, note minutes and actions), and document/publish discussion, actions and decisions.
• Capture and track actions, decisions, issues, and risks identified during the safety governance meetings. Follow through on actions to completion.
• Train and mentor new team members.
• 20% Travel.

Qualifications/ Required

Knowledge/ Experience and Skills:

Knowledge/Experience

• Minimum of 5 years of experience in pharmacovigilance, with at least 2-4 years specifically in aggregate reporting and RMP operations
• In-depth knowledge of global pharmacovigilance regulations, including ICH guidelines and EMA/FDA requirements
• Strong understanding of medical terminology and ability to understand safety data
• Experience working with Alliance Partners and understanding Pharmacovigilance Agreements
• Experience with CA inspections (PV and GCP)
• Experience managing vendors
• Experience with Electronic Document Management Systems (EDMS), SharePoint & Safety Databases (ex. Argus) is a plus
• Experience working in a Matrix environment

Skills

• Excellent project management skills with the ability to manage multiple projects simultaneously
• Strong leadership skills with excellent decision making and judgement
• Strong written, verbal communication/presentation and meeting facilitation skills
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Vendor Management; Operations management
• Process creation (SOP development)

Educational Qualifications Required:

BS degree in Life Sciences field or related equivalent field with minimum of 5 years of experience in the pharmaceutical industry. Pharm D or nursing degree is a plus.

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