Manager, US Commercial Pharmacovigilance

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:
Pharmacovigilance

Job Category:
People Leader

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for Manager, US Commercial Pharmacovigilance to be in Titusville, NJ.

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

This individual has responsibility for pharmacovigilance oversight in support of the US Pharmacovigilance Officer (PVO) to ensure the compliant management of internal and external organizations that are required to report adverse events and product quality complaints from US Commercial Operating Company activities.
? Ensures compliant program management for safety reporting in accordance with US and international reporting regulations, company policies and Standard Operating Procedures (SOPs)
? Effectively partners and educates US Operating Company (OpCo) functions (e.g., Medical Affairs, Market Research, Real World Evidence, Patient Engagement Customer Solutions) to ensure that all US OpCo programs are compliant with the relevant safety reporting policies, procedures and guidelines
? Proactively partners with stakeholders to ensure audit and inspection readiness
? Manages risk associated with suppliers conducting programs on behalf of US OpCo; leverages innovation to improve areas of deficiency
? Monitors timely submission of complaints generated from US OpCo activities, investigates and maintains documentation of non-compliance
? Provides inspection ready documentation for late health authority reporting
? Performs trend analysis; identifies issues and opportunities for continuous improvement of PV processes. Leverages existing and new technology to assist in solution development
? Develops compliance metrics as necessary to demonstrate oversight and identify trends
? Ensures USCPV technical requirements are included during system implementations/change releases to facilitate continued access to data that support AE/PQC reporting and oversight activities
? Drives corrective and preventative actions to address audit and inspection findings related to external partner safety reporting and ensures that responses are executed compliantly
? Designs and delivers training programs associated with pharmacovigilance

Qualifications / Requirements:

Education:
? BA/BS degree required

Experience and Skills:
? Prior experience in a safety or compliance role (i.e. - prior experience with regulatory mandated processes for handling adverse events and product quality complaints. Experience interfacing with auditing and compliance organization)
? Knowledge of drug safety regulations and reporting processes
? Understanding of medical, pharmacology, or nursing terminology (preferred)
? Knowledge of Good Pharmacovigilance Practices (GPvP) (preferred)
? Familiarity with Janssen Scientific Affairs-supported products (preferred)
? Strong critical thinking skills demonstrated in problem-solving and overcoming obstacles
? Excellent communication and influencing skills to effectively interface with multiple parties, shaping development and implementing processes
? Excellent planning, organizational, and interpersonal skills

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

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