Stryker

Staff Specialist, Adverse Event Reporting

Stryker

Flower Mound, TX, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

At Stryker, we strive to improve patient outcomes and make a difference in the world of healthcare. As a Staff Specialist for Adverse Event Reporting, you will play a crucial role in ensuring the safety and quality of our products. We are seeking a highly motivated individual with a background in medical device adverse event reporting and a passion for patient safety. If you are detail-oriented, have excellent communication skills, and are dedicated to making a positive impact in healthcare, we want you on our team. Join us in our mission to make healthcare better.

  1. Conduct thorough investigations and analysis of adverse events associated with Stryker medical devices.
  2. Review and evaluate complaints and adverse event reports to ensure accuracy and completeness.
  3. Collaborate with cross-functional teams to gather and analyze data related to adverse events and identify trends or patterns.
  4. Develop and implement strategies to mitigate risks associated with adverse events.
  5. Maintain knowledge of relevant regulations and industry standards related to adverse event reporting.
  6. Communicate with healthcare professionals, patients, and regulatory bodies to report and resolve adverse events.
  7. Provide guidance and training to internal teams on adverse event reporting processes and procedures.
  8. Monitor and track adverse event reports and ensure timely and accurate submission to regulatory agencies.
  9. Conduct root cause analysis and implement corrective and preventive actions related to adverse events.
  10. Participate in risk management activities, including risk assessments and risk management plans.
  11. Collaborate with product development teams to ensure adverse event reporting requirements are incorporated into design and development processes.
  12. Serve as the subject matter expert on adverse event reporting for Stryker products.
  13. Maintain accurate and complete records of all adverse event reports and related documentation.
  14. Continuously evaluate and improve adverse event reporting processes and procedures to ensure compliance and efficiency.
  15. Act as a representative of Stryker in interactions with regulatory agencies, healthcare professionals, and other stakeholders regarding adverse events.
Where is this job?
This job is located at Flower Mound, TX, USA
Job Qualifications
  • Bachelor's Degree In A Relevant Field Such As Healthcare Administration, Nursing, Or Pharmacology.

  • Minimum Of 3-5 Years Of Experience In Adverse Event Reporting, Preferably In The Medical Device Or Pharmaceutical Industry.

  • In-Depth Knowledge Of Fda Regulations And Guidelines Related To Adverse Event Reporting And Medical Device Reporting.

  • Strong Analytical Skills And Attention To Detail, With The Ability To Effectively Identify, Investigate, And Report Adverse Events.

  • Excellent Communication And Interpersonal Skills, With The Ability To Collaborate With Cross-Functional Teams And Effectively Communicate Adverse Event Data To Stakeholders.

Required Skills
  • Quality Assurance

  • Communication Skills

  • Project Management

  • Data Analysis

  • Report Writing

  • Medical Terminology

  • Risk assessment

  • Investigative skills

  • Regulatory compliance

  • Team collaboration

  • Problem-Solving

  • Attention

Soft Skills
  • Communication

  • Conflict Resolution

  • Customer Service

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Staff Specialist, Adverse Event Reporting in Flower Mound, TX, USA is $57,000-$75,000 per year. This may vary depending on the specific company, experience level, and other factors.

Additional Information
Stryker is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMay 16th, 2024
Apply BeforeJune 9th, 2026
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About Stryker

Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.

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