Senior Manager PV Operations (Global Case Processing)
Posted on: January 15, 2022
Position SummaryThe 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 ResponsibilitiesPV
- 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
- 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 inspectionsKnowledge, Skills, Competencies,
Education, and ExperienceKnowledge------------
- Requires knowledge of industry terminology, global PV
legislative and regulatory frameworks
- Familiarity with drug safety databasesSkills
- 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
- Excellent command of written and spoken EnglishCompetencies
- 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
- Problem solving and analytical skills
- Strategic and tactful communication and negotiation
skillsEducation 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 EnvironmentTravel
(approximately 10%)Come discover more about Otsuka and our benefit
offerings;--.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 ScamsJob
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.
Keywords: Otsuka, Trenton , Senior Manager PV Operations (Global Case Processing), Executive , Princeton, New Jersey
Didn't find what you're looking for? Search again!