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||Princeton, NJ United States
Senior Manager PV Operations (Global Case Processing)|
The PV Operations Manager will lead product and PV project related activities, support oversight of the PV operational and case management activities as well as contract resources performing these activities.
Key Job Responsibilities
PV Operations Manager
Have a working knowledge of end to end case processing including MedDRA and WHO-DD coding.
Have a working knowledge of ICH guidelines, US and EU PV regulations for pre- and post-marketed products.
Support the collection, processing, and/or reporting of safety information for all Otsuka Products.
Ensure compliance with procedures and reporting timelines
Support or lead global ICSR literature search activities.
Collaborate with the Compliance and Business Management team to review case quality, oversee case correction activities, and support the oversight of case compliance.
Lead product and study related PV activities for assigned products including the review of Safety Management Plans, protocols, and Pharmacovigilance Agreements, team meeting attendance, and general PV support.
Collaborate with Global Safety Data Management for various PV Projects which may include but are not limited to: developing and monitoring reports, process improvements, database change testing, study, product and reporting rule configurations, new database implementations or enhancements, and support of the Intake tool and Reconciliation tool.
Support the training of Safety Associate and Specialist
Support the safety support collaboration with affiliates, partners, and vendors.
Collaborate with Medical Safety team to ensure appropriate decision making around case assessments.
Escalate issues to management as needed
Demonstrate leadership within and outside PV Operations
Surface recommendations for process improvements or new business needs to PV Operations Management
Supports PV Operations in the management of the PV training curriculum assignment process
Act as subject matter expert for PV Operations during audits and regulatory inspections
Knowledge, Skills, Competencies, Education, and Experience
Requires knowledge of industry terminology, global PV legislative and regulatory frameworks
Familiarity with drug safety databases
Ability to use software applications to track databases.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Excellent command of written and spoken English
Proven ability to work in a team environment and influence decisions with and without authority
Ability to network across various functional areas within Otsuka
Problem solving and analytical skills
Strategic and tactful communication and negotiation skills
Education and Related Experience
Bachelor degree in a scientific field, preferably in the health sciences area (e.g., Nursing, Pharmacy)
Minimum of 2 years of case processing experience in the pharmaceutical industry.
Physical Demands and Work Environment
Travel (approximately 10%)
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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