Senior Techno-Vigilance Analyst - Pharmacovigilance & Quality

Johnson & Johnson Innovative Medicine; Bogotá; On-site; COP 270,537,000 - 397,848,000; Full time

Job summary

Johnson & Johnson is seeking a CQ Sr. Analyst Techno-vigilance for the Mexico City area to support drug safety and vigilance activities across the product lifecycle.

The role focuses on identifying and mitigating safety risks, with collaboration across clinical, medical, and regulatory teams. Qualified candidates will have a minimum of 3 years in pharmacovigilance and techno-vigilance, strong RCA and QA/QMS experience, and proficiency in Spanish (English preferred).

Qualifications

• Min 3 years of experience in Pharmacovigilance and Techno vigilance activities
• Demonstrates skills and competencies in process optimization, quality management systems (QMS)
• Serious adverse event reporting, report writing, health intelligence, safety orientation
• Root cause analysis (RCA)
• Clinical operations, regulatory affairs management, pharmacovigilance, performance measurement, critical thinking, and safety investigations.
• Languages: Spanish required; English proficiency preferred.

Responsibilities

• Conduces root cause analyses and investigations related to signal detection and performs safety monitoring activities to identify, assess, and manage risks.
• Conducts medical devices/drug safety monitoring and follow-up in accordance with the organization’s standards and protocols.
• Prepares and delivers reports and presentations based on customers’ use of the organization’s products.
• Implements risk-based systems, with minimal supervision, to identify, assess, and manage techno vigilance /pharmacovigilance requirements.
• Assesses safety data and signals as part of ongoing techno vigilance/pharmacovigilance activities.
• Provides recommendations to improve processes and systems supporting the techno vigilance/Pharmacovigilance department’s activities.
• Responds to inquiries from external stakeholders regarding the organization’s product information and new developments.
• Trains less-experienced colleagues on techniques, processes, and responsibilities.

Skills

Pharmacovigilance

Techno vigilance

Root cause analysis

Quality management

Adverse event reporting

Regulatory affairs

Safety investigations

Spanish

English proficiency

Data analysis

Education

Chemistry, medicine, pharmacy (QFB), or biomedical engineering

Job description

Johnson & Johnson is seeking a CQ Sr. Analyst Techno-vigilance for the Mexico City area to support drug safety and vigilance activities across the product lifecycle.

The role focuses on identifying and mitigating safety risks, with collaboration across clinical, medical, and regulatory teams. Qualified candidates will have a minimum of 3 years in pharmacovigilance and techno-vigilance, strong RCA and QA/QMS experience, and proficiency in Spanish (English preferred).