Senior Safety Officer, MedTech Vision at Johnson & Johnson

Jacksonville, Florida, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Vision CareIndustries

Requirements

Doctor of Medicine (MD) or equivalent (e.g., MBChB) with specialization in Ophthalmic Surgery
Minimum of 5 years clinical experience in Ophthalmic Surgery
10 years or more clinical, pharmaceutical and/or medical device experience
Required skills: Clinical Operations, Compliance Management, Design Mindset, Developing Others, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Program Management, Quality Control (QC), Research Ethics, Risk Compliance, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Succession Planning, Surveillance

Responsibilities

Own end-to-end risk-benefit assessments for Vision Care in partnership with the MSO for Surgical Vision, delivering robust Risk Management Reports, Health Risk Evaluations, and Clinical Evaluation Reports to inform benefit-risk conclusions
Lead Product Safety Surveillance Plans (SSPs) and risk categorization for product families, ensuring timely input into safety responses to Adverse Events (AEs), complaints, and mass communications
Provide expert interpretation of post-marketing safety data, aggregate complaint data, and literature reports; supervise First in Human Committee triage and safety signal evaluations
Chair Safety Management Teams, serve on the QRB as the Medical Safety representative, and drive consistency in medical evaluations and QRB decisions across the Vision portfolio
Ensure Medical Safety training and competency development for MSOs, and secure necessary resources by partnering with responsible functions to close gaps quickly
Align safety processes with enterprise Safety Principles, MD CSO/CMO guidance, and Quality Risk Management; support due-diligence activities for potential MedTech acquisitions
Track and improve safety performance through defined metrics (e.g., timeliness of risk assessments, SSP milestone completion, training completion rates, and effectiveness of safety communications)

Skills

Product Safety

Risk Management

Risk-Benefit Assessment

Safety Surveillance

Adverse Event Management

Clinical Evaluation

Regulatory Reporting

Medical Affairs

Health Authority Communication

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

Land your dream remote job 3x faster with AI

Try Jobo Free