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 Development - Play an active role in professional development as a business imperative.

Minimum $131,153.00 - Maximum $187,550.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

 

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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