CQ Sr Analyst Techno-vigilance, Colombia

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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia

Job Description:

DePuy Synthes is recruiting for a CQ Sr Analyst Techno-vigilance, Colombia, located in Bogota, Colombia.

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

Education

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

 

Experience and Skills

Required

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 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.

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.

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Required Skills:

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