CQ Sr Analyst Techno-vigilance, Colombia

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.

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

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

• →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.

Education

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

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.

• Languages: Spanish required, English proficiency preferred.
• Travel: Limited domestic or international travel may be required (generally <10%).

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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