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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Product Safety
Job Sub Function:
Pharmacovigilance
Job Category:
Scientific/Technology
All Job Posting Locations:
São Paulo, Brazil
Job Description:
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
Remote work options may be considered on a case-by-case basis and if approved by the Company.
We are searching for the best talent for Pharmacovigilance Jr Analyst.
Purpose: Responsibility for adverse events triage and timely submission of Individual Case Safety Reports - ICSRs (Adverse Events, Adverse Events associated with Product Quality Complaints – PQCs, and Special Situations) to Global Processing Center and Local Health Authorities.
Support Pharmacovigilance (PV) activities to ensure that LOC (Local Operating Company) PV processes are managed in compliance with Local regulations and Company policies/procedures and in accordance with any PV agreements with business partners.
You will be responsible for:
Case Management (intake/follow-up/outbound)
Perform and/or support vendor on triage and intake of Adverse Event/Special Situation, including those associated with PQCs, received by Regional Pharmacovigilance in Latin America to be submitted to the appropriate Processing Center and Local Regulatory Authorities (covering at least one Latin America region). Act in accordance with internal and regulatory requirements, including agreements with Business Partners.
Perform and/or support vendor on quality reviews in accordance with internal procedures.
Respond and/or support vendor on queries that may be generated from global case processing.
Perform and/or support vendor on follow-up attempts for valid and invalid cases in accordance with internal and regulatory requirements, including Targeted Follow-up Questionnaires (TFUQs), whenever applicable. Ensure the process is tracked as appropriate.
Perform and/or support vendor on associated reconciliations as required by internal procedures.
Conduct case management-related training to vendor team and/or newcomers.
Support the investigation, documentation, and corrective/preventive action implementation for late cases submission as required.
Literature Search
Perform Regional scientific literature review for the identification of safety information in accordance with internal and regulatory requirements. Ensure the process is properly documented and updated.
Project Support
Participation in Pharmacovigilance-related projects.
Qualifications / Requirements:
Any Health Care career or equivalent, with oral and written proficiency in English.
Degree Completed.
Desirable Experience in Pharmaceutical Industry or related.
Intermediate Spanish Level.
Other Requirements
Capability to manage multiple projects simultaneously.
Excellent computer-based application skills.
Analytical and detail-oriented profile.
Good communication skills.
Organizational skills.
Required Skills:
Preferred Skills:
