Manager, Product Event Library and Dictionary Management (PELDM)

Johnson and Johnson; Columbia (SC); Remote; USD 115,000 - 198,000; Full time

Job summary

An established industry player is seeking a skilled Manager for Product Event Library and Dictionary Management. This remote role involves leading operational activities for adverse event and drug dictionaries, ensuring compliance with safety reporting requirements. You will collaborate with cross-functional teams and drive strategic initiatives to enhance product configuration standards. If you're passionate about improving healthcare through innovative solutions and have a strong background in the pharmaceutical industry, this opportunity offers a chance to make a significant impact in a dynamic environment.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Paid Time Off

Short-term Disability

Long-term Disability

Life Insurance

Employee Assistance Program

Flexible Work Hours

Qualifications

• 6-8 years experience in the pharmaceutical or healthcare industry.
• Expertise in MedDRA and WHO DD medical dictionaries.
• Ability to train personnel on dictionary use and coding principles.

Responsibilities

• Lead operational activities for product event library management.
• Develop processes for product configuration within the safety database.
• Interface with stakeholders and manage deliverables for PELDM.

Skills

Medical Coding

Data Retrieval

Pharmacovigilance

Effective Communication

Workflow Coordination

Education

Bachelor's Degree

Registered Nurse

PhD

Tools

Microsoft Suite

Aris Global LSMV

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https : / / www.jnj.com

Job Function : Product Safety

Job Sub Function :

Drug & Product Safety Operations

Job Category : Professional

All Job Posting Locations :

Athens, Georgia, United States of America, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, West Virginia, United States, Cincinnati, Ohio, United States of America, Columbia, South Carolina, United States, Detroit, Michigan, United States, Greenwich, Connecticut, United States of America, Knoxville, Tennessee, United States, Manchester, New Hampshire, United States, Mooresville, Indiana, United States of America, New York, New York, United States, Providence, Rhode Island, United States of America, Richmond, Virginia, United States of America, Rockville, Maryland, United States of America, Shepherdsville, Kentucky, United States of America, South Portland, Maine, United States of America, Spring House, Pennsylvania, United States of America, Tampa, Florida, United States of America, Titusville, New Jersey, United States of America, Washington, District of Columbia, United States of America, Wilmington, Delaware, United States, Wilson, North Carolina, United States of America

Job Description :

About Innovative Medicine :

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https : / / www.jnj.com / innovative-medicine

We are searching for the best talent for a Manager, Product Event Library and Dictionary Management (PELDM) to be located remotely within the United States in the Eastern Time Zone (ET).

This is a remote role available in multiple states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the states where this opportunity is available.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose :

This position is responsible for leading the Product Event Library and Dictionary Management (PELDM) group's operational activities for the administration and maintenance of standard adverse event and drug dictionaries used within Global Medical Safety Organization (GMSO). This includes medical coding, data retrieval of adverse event and other safety data (medical history, disease states, and indications) using MedDRA terminology as well as concomitant medication data using WHO DD terminology. This position supports company product event libraries, system configuration activities, auto-labeling, watchlists, and other safety reporting requirements. The position will also assist the Director in strategic operational initiatives related to MedDRA and WHO DD. This position also contributes to the administration and maintenance of the Company Product Dictionary within the global safety system. Additionally, the position will be a Subject Matter Expert (SME) for the PELDM group.

The Manager of PELDM will liaise closely with all stakeholders including case management, medical reviewers, the local safety officers, safety reporting and compliance team; and represent the group on various cross-functional initiatives, activities, and projects.

You will be responsible for :

• Define, develop, and maintain product configuration standards within the global safety database that meet business requirements
• Develop processes and efficiencies for product and library list configuration within the global safety database
• Lead strategist and primary point of contact for other functional groups seeking assistance requiring product configuration expertise
• Develop, manage and optimize operational metrics and support innovation activities
• Lead and support projects such as safety database transition and various other databases and platforms
• Lead QI / NC, CAPA, oversight, and other business-related processes
• Interface with internal and external stakeholders and manage PELDM deliverables
• Lead local and international multidisciplinary functional teams, internal and external audit and inspection activities for PELDM
• Lead strategist for any future enhancements within the current global safety database, improving efficiencies related to PELDM processes.

Qualifications / Requirements :

Education :

• Minimum of Bachelor's degree is required
• Registered Nurse, Pharmacist, PhD is highly preferred

Required :

• 6-8 years experience in the pharmaceutical industry and / or healthcare industry
• Relevant product dictionary experience and expertise in MedDRA, WHO DD, & other medical dictionaries
• Knowledge of Pharmacovigilance processes in relation to medical dictionaries
• Ability to organize training activities and train personnel regarding dictionary use and coding principles as they relate to drug safety
• Practical knowledge of applicable global, regional and local regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Effective communication skills (verbal and written) and strong presentation skills to fit target audience and key stakeholders
• Ability to coordinate and harmonize workflow activities with the team, evaluate processes and suggest ways to improve efficiency, accuracy and compliance
• Ability to work independently to investigate and resolve issues
• Ability to thrive in a global, matrix, high volume environment
• Ability to evaluate, plan and work under very tight timelines with constantly changing priorities to meet corporate deadlines
• Proficiency in Microsoft Suite; i.e., Word, Excel, PowerPoint
• Clear and concise documentation skills

Preferred :

• Experience with Aris Global LSMV (LifeSphere MultiVigilance) system

The anticipated base pay range for this position in the US is $115,000 to $197,800.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits :

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to : https : / / www.careers.jnj.com / employee-benefits

This job posting is anticipated to close on May 5, 2025. The Company may however extend this time-period, in which case the posting will remain available on https : / / www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([emailprotected] ) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

115,000-197,800

Additional Description for Pay Transparency :

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits : Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http : / / www.careers.jnj.com / employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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Library Manager • Columbia, SC, United States