Pharmacovigilance Supervisor - CDMX

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:
Mexico City, Mexico

Job Description:

REGULATORY COMPLIANCE
▪ Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance.

Accountable internally for ensuring that the LOC meets procedure defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
▪ Oversight responsibilities of case processing operational activities delegated to the Center of Excellence Case Processing hub for Latin America or external vendor as appropriate.

Case processing activities include but not limited to Inbound reporting, outbound reporting, translation of AEs/Special Reporting Situations/PQCs, literature search, due diligence.
▪ Accountable for compliance monitoring for submissions to Competent Authorities (HAs).

Reconcile compliance data provided and take appropriate corrective actions as defined by company policies and procedures.
▪ Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities.

Inform the appropriate global and regional groups (i.e.

QPPV office and regional heads) of any changes to local laws and regulations regarding Pharmacovigilance
▪ Oversight of timely elaboration and submission of all documents required by local PV legislation.

PV SYSTEMS COMPLIANCE
▪ Oversight of timely and appropriate communication & follow up of the activities related with Global Clinical Operations (GCO & GCO MAO) to comply with PV local regulations regarding clinical trials conducted in the territory as applicable, including those carried out by third parties, as per the contracts & agreements.
▪ Oversight of timely and appropriate Development of Local Implementation Memos (LIM) for Regional / PV Standard Operating Procedures/Working Practices and verify adherence.
▪ Managing and scheduling of the preparation of necessary outlines, status reports, graphs, charts, tables, and slides for periodic reviews for the Pharmacovigilance specialists.
▪ Monitor data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g.

patient support programs, market research studies, marketing activities, internet sites, surveys, etc.), as applic...