Manager, Product Event Library and Dictionary Management (PELDM)

Johnson & Johnson Innovative Medicine; Washington (District of Columbia); Remote; USD 115,000 - 198,000; Full time

Job summary

A forward-thinking company is seeking a dynamic Manager for Product Event Library and Dictionary Management. This pivotal role involves leading operational activities, managing product dictionaries, and collaborating with multidisciplinary teams to enhance safety reporting processes. The ideal candidate will have a strong background in pharmacovigilance, excellent communication skills, and proficiency in regulatory guidelines. Join a team dedicated to developing innovative healthcare solutions and make a meaningful impact on patient safety and treatment efficacy. This is an exciting opportunity to contribute to groundbreaking advancements in the pharmaceutical industry.

Benefits

Performance Bonuses

Comprehensive Benefits

Time-off Benefits

Company-sponsored Benefit Programs

Qualifications

• 6-8 years in the pharmaceutical or healthcare industry.
• Expertise in product dictionaries and regulatory requirements.

Responsibilities

• Lead operational activities of the PELDM group.
• Manage product configuration standards and quality initiatives.

Skills

MedDRA

WHO DD

Pharmacovigilance

Communication Skills

Microsoft Office Suite

Education

Bachelor's Degree

RN, Pharmacist, or PhD

Tools

Aris Global LSMV

Job description

Manager, Product Event Library and Dictionary Management (PELDM)

Join us to apply for the Manager, Product Event Library and Dictionary Management (PELDM) role at Johnson & Johnson Innovative Medicine.

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 seeking a Manager, Product Event Library and Dictionary Management (PELDM) to be located remotely within the United States, preferably in the Eastern Time Zone (ET). This is a remote role available across multiple states; specific cities listed are examples and do not limit your application. Remote work options may be considered case-by-case and upon approval.

Purpose: This role leads the operational activities of the PELDM group, managing the administration and maintenance of standard adverse event and drug dictionaries within the Global Medical Safety Organization (GMSO). Responsibilities include medical coding, data retrieval using MedDRA and WHO DD terminology, supporting product event libraries, system configuration, auto-labeling, watchlists, and safety reporting. The role also involves strategic initiatives related to MedDRA and WHO DD, and administration of the Company Product Dictionary within the global safety system. The Manager will serve as a Subject Matter Expert (SME) and liaise with stakeholders across functions.

You Will Be Responsible For:

• Define, develop, and maintain product configuration standards within the global safety database.
• Develop processes for product and library list configuration.
• Lead the strategy and serve as the primary contact for product configuration needs.
• Manage operational metrics and support innovation initiatives.
• Lead projects such as safety database transitions and platform enhancements.
• Oversee quality initiatives, audits, and inspections related to PELDM.
• Collaborate with stakeholders, managing PELDM deliverables.
• Lead multidisciplinary teams and support regulatory audits.
• Strategize for future database enhancements to improve efficiency.

Qualifications / Requirements:

• Bachelor’s degree required; RN, Pharmacist, or PhD preferred.
• 6-8 years of experience in the pharmaceutical or healthcare industry.
• Expertise in product dictionaries, MedDRA, WHO DD, and related medical dictionaries.
• Knowledge of pharmacovigilance processes and regulatory requirements.
• Ability to train personnel in dictionary use and coding principles.
• Proficiency in global regulatory guidelines (GCP, ICH).
• Excellent communication and presentation skills.
• Ability to work independently and in a global, high-volume environment.
• Proficiency in Microsoft Office Suite.

Preferred:

• Experience with Aris Global LSMV system.

The anticipated base pay range is $115,000 to $197,800, with performance bonuses and comprehensive benefits. The role is eligible for various time-off benefits and participation in company-sponsored benefit programs. The job posting closes on May 5, 2025, but may be extended. Johnson & Johnson is an Equal Opportunity Employer and provides accommodations for applicants with disabilities.