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Sr. Medical Device Safety Specialist

Source One Technical Solutions Fort Worth, TX
  • Expired: over a month ago. Applications are no longer accepted.

Seeking a Sr. Medical Device Safety Specialist for a consulting position at a pharmaceutical client in Fort Worth, TX 76134.

Position Purpose:
Support the Medical Safety team in post-market surveillance and quality management activities

Major Accountabilities:
- Assist in the preparation high quality and regulatory compliant safety documents, including post-market surveillance plans, risk management files, and periodic safety update reports
- Assist in the evaluation of product safety profiles, including literature reviews, safety analyses, and narrative writing
- Assist with process harmonization, simplification and development of standard operating procedures
- Drive improvements in safety operations, signal management, and safety documents as required by applicable regulations
- Collaborate with internal and external stakeholders to resolve safety-related issues effectively, efficiently and in a timely manner

- Proficient in Microsoft Office suite of applications
- Ability to work independently and meet targeted timelines in a team-centric environment
- Solid interpersonal, communication (verbal and written), and presentation skills
- Demonstrates attention to detail, strategic thinking and problem solving skills

- Master of Science or health-related discipline is required

- Minimum 5 years of pharmaceutical or medical device industry experience (required)
- Prior experience in safety operations or medical safety with working knowledge in case processing, signal management, and global safety regulations (required)
- Prior experience in process development and business integrations (strongly preferred)
- Clinical expertise in ophthalmic products (strongly preferred)

Source One Technical Solutions

Why Work Here?

We are a well-established (20 years in business) consulting services company headquartered in Branchburg, NJ.

A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.


Fort Worth, TX