CQ Sr. Analyst Techno-vigilance, Mexico

Brighter Signals; Bogotá ciudad; Sur place; MXN 700 000 - 900 000; Plein temps

Résumé du poste

DePuy Synthes in Mexico City seeks a CQ Sr. Analyst Techno-vigilance to support pharmacovigilance and drug safety processes across discovery to regulatory approval, applying scientific and clinical expertise to identify and respond to safety signals. You will collaborate across disciplines, perform RCA, risk assessments, and prepare reports.

Spanish required, English preferred; travel limited. Johnson & Johnson is an Equal Opportunity Employer and promotes an inclusive interview process for

Qualifications

• Minimum 3 years of experience in Pharmacovigilance and techno-vigilance activities.
• Experience with quality management systems (QMS).
• Proficient in adverse event reporting, health intelligence, and safety orientation.
• Strong analytical and problem-solving skills including RCA.
• Knowledge of clinical operations, regulatory affairs, and pharmacovigilance metrics.

Responsabilités

• Conducts root cause analyses and investigations for signal detection and safety monitoring.
• Performs safety monitoring for medical devices and drugs per standards.
• Prepares and delivers reports based on product safety data.
• Implements risk-based systems to identify and manage pharmacovigilance requirements.
• Assesses safety data and signals as part of techno-vigilance activities.
• Provides recommendations to improve processes and systems in pharmacovigilance.
• Responds to inquiries from external stakeholders regarding product information.
• Trains less-experienced colleagues on techniques and responsibilities.

Connaissances

Pharmacovigilance

Techno vigilance

Quality management systems

Root cause analysis

Clinical operations

Regulatory affairs

Data analysis

Formation

Chemistry/Medicine/Pharmacy/ Biomedical engineering

Description du poste

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia, Mexico City, Mexico

Job Description

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

DePuy Synthes is recruiting for a CQ Sr. Analyst Techno-vigilance, Mexico located in Mexico City, DF, Mexico

Job Overview

Experienced professional in a scientific or technological field. Supports the operational, medical, and scientific components of the organization’s drug safety and techno vigilance/pharmacovigilance processes and procedures. Contributes scientific, pharmaceutical, medical devices and clinical expertise, with a strategic focus on identifying, assessing, and responding to safety risks and detecting signals related to the organization’s products. Collaborates across disciplines to actively manage and mitigate risks as clinical, medical and pharmaceutical products progress from discovery and preclinical phases through clinical trials and regulatory approval

Key Responsibilities

• Conducts 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.

Qualifications

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

Required

Experience and Skills

• 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.

Other

• Languages: Spanish required, English proficiency preferred.

Travel: Limited domestic or international travel may be required (generally

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#DePuySynthesCareers

Preferred Skills

• Audit Management


• Business Behavior


• Coaching


• Compliance Management


• Continuous Improvement


• Data Analysis
  
• Detail-Oriented


• Goal Attainment


• Internal Controls


• Issue Escalation


• Problem Solving


• Process Oriented


• Quality Control (QC)


• Quality Management Systems (QMS)


• Quality Standards


• Regulatory Environment