Senior Manager, Compliance & Business Management

JOB_REQUIREMENTS

Hires in

Not specified

Employment Type

Not specified

Company Location

Not specified

Salary

Not specified

Job Description

The Senior Manager, Global Pharmacovigilance (GPV) Compliance & Business Management (CBM), will support in the development and implementation of necessary processes for the management of routine compliance activities within the pharmacovigilance organization. This is a global role. The job holder will also work collaboratively with other GPV groups, Affiliate PV Coordination Group (APVC), Global Quality Operations (GQO), the Global QPPV office and Regional Pharmacovigilance Heads to identify and meet various Global CBM objectives.

At the discretion of the Global Head of CBM, it may be required to support activities within multi sub-function project teams as needed.

Key Responsibilities:

GPV Alliance Management (GPVAM)

Responsible for supporting the development and maintenance of Pharmacovigilance Agreements (PVAs).
Responsible for ensuring compliance with global, local and regional PV regulations and policies/procedures and take corrective and/or preventive actions, when needed and as applicable to PVAs.
Support PV audits/inspections and assist in developing CAPAs in response to findings/observations in relation to PVAs and compliance.
Manage routine compliance metrics in pharmacovigilance activities related to PVAs.
Perform impact analysis regarding PV compliance strategies and work instructions including input into PVAs.
Participate in the root cause analysis, identification and investigation of non-adherence (deviations) to PV requirements in accordance with the PVA or PVA processes.
Facilitate round table reviews/comments resolution meetings as needed.
Support other GPVAM activities as applicable.

GPV Compliance & Analytics

Responsible for compiling compliance metrics according to local and regional PV regulations and Otsuka's policies/procedures and to request implementation of corrective and/or preventive actions, when needed.
Ensure implementation of relevant updates to PV regulations to the impacted tasks in scope of the role, within the required timeline.
Develop and implement metrics and dashboards to ensure regulatory requirements for PV are compiled and risks are minimized.
Facilitate early detection of potential compliance through trend analyses and subsequent timely reporting to the relevant regional stakeholders (e.g. in Europe the EU-QPPV has to be included).
Responsible for driving automation and innovation in compliance monitoring.

Additional Activities

Attend Global / Regional meetings as required.
Present compliance metrics at Global Meetings.
Contribute to maintenance of PV System Master File as required.
May be assigned to lead or assist with special projects or process development.
May perform any other duties as needed.

Job Scope (key facts & figures)

Travel as applicable
Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance.
Solid background and experience in pharmaceutical quality system management (GxP).
Experience with participation in PV audits in the pharmaceutical industry.
Strong project management, interpersonal, communication and presentation skills.
Ability to accomplish objectives through influence in a matrix organization.
Strong computer skills with Word, Excel, PowerPoint, and Outlook.

Qualifications/ Experience Required

Bachelor's degree
Expertise in Good Pharmacovigilance Practice (GPvP)
Technical skills & experience
Minimum 2 years PV Compliance or Quality Management experience in the pharmaceutical industry.
Microsoft proficient

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 $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

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

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website

https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at:

https://www.ic3.gov

, or your local authorities.

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.

Similar jobs