Kelly Services Safety Physician - Vision Care in Fort Worth, Texas

Kelly Services is seeking a Safely Physician with Ophthalmology experience to join our leading client for a W2 contract opportunity. This candidate can be located in Fort Worth, TX or Atlanta, GA . The duration of this assignment is 1 year.

Safety Lead – Vision Care (contractor)

Perform device safety activities for assigned product lines (contact lenses and lens care solutions), including identification and comprehensive assessment of safety signals from all sources.

Key Performance Indicators

  • Timeliness and quality of safety analyses, interpretations and presentations

  • Compliance with internal and external regulations and procedures

Major Activities

  1. Perform single case medical review in the safety database or line listings. Medical review will be performed by clinically/medically qualified associates.

  2. Monitor the clinical safety of assigned product lines (contact lenses and lens care solutions), including literature review, adverse events, patient impact from technical complaints, and signal detection.

  3. Provide safety input into clinical and regulatory deliverables, including Investigator’s Brochures, study protocols, reports, and clinical submission documents, as needed.

  4. Identify safety signals based on the review of solicited or unsolicited single cases. Performs signal triage activities, evaluation, and presentation to governance boards including preparatory activities.

  5. Author or provide safety input to the product labeling and related documents.

  6. Contribute to the safety profiling and risk management documents.

  7. Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports.

  8. Provide relevant safety input and collaborates productively with colleagues across business franchise functions.

  9. Provide medical/scientific input into responses to inquiries from health authorities, healthcare professionals, or local affiliates on safety issues. Prepares safety data for health authority review boards.

  10. Support licensing activities, health authority inspections/audits, and project/product recall activities, as needed.

Ideal Background

Education:

  • OD degree, J.D., M.D., D.D.S. or Pharm. D.

Languages:

  • Fluent in spoken and written English.

  • Knowledge of other languages desirable.

Experience/Professional:

  • At least 3 years of industry experience in product development, including 1 year in safety at an operational or medical position.

  • Clinical knowledge of ocular anatomy and ophthalmic procedures.

  • Proven ability to analyze, interpret, and discuss safety information. Good written and verbal communication.

  • Experience in product development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.

  • Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.

  • Demonstrates strategic thinking and problem solving skills.

  • Experience with (safety or others) issue management.

  • Ability to work independently and meet targeted timelines.

Preference:

  • At least 1 year of clinical experience post-doctoral.

  • Technical expertise in ophthalmic medical devices.

Additional Information:

  • Contract assignment, duration 12 months.

  • Work schedule: full-time, first shift.

Kelly Temporary Employee Perks:

  • Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable*

  • Service bonus plan and Holiday pay plan, if qualified

  • Weekly electronic pay options

  • Free online training campus available

  • Exclusive online employee community

  • Corporate discounts

Apply Now!

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:

Sandy at: Sanm174@KellyServices.com

Thank you for your interest in the assignment.

Why Kelly ® ?

At Kelly

Services ® , we work with the best. Our clients include 95 of the Fortune

100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to access

the best talent to drive their business forward. If you only make one career connection today, connect

with Kelly.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people

around the world and have a role in connecting thousands more with work through our global network of

talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.