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Job Title: Manager, Case Processing
Location: Princeton, NJ United States
Position Type: Full Time
Post Date: 10/08/2021
Expire Date: 12/08/2021
Job Categories: Biotechnology and Pharmaceutical
Job Description
Manager, Case Processing
Description:

Position Summary

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

Have a working k

nowledge 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, proces
s
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

Know
ledg
e

Requires knowledge of industry terminology, global PV legislative and regulatory frameworks

Familiarity with drug safety databases

Skills

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

Competencies

Proven ability to work in a team environment and influence decisions with and without authority

Customer orientation

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
, pref
erably 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.

Statement Regarding Job Recruiting Fraud Scams

Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
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Contact Information
Contact Email:Mitzi.Sacks@otsuka-us.com
Website:https://www.aplitrak.com/?adid=YmJnZW5lcmljLjQ1NTk2LjM2NTlAb3RzdWthLmFwbGl0cmFrLmNvbQ
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