Manager, Global Medical Safety - Perm - Atlantic Partners Corporation

As a Manager, Global Medical Safety you will serve as the medical and scientific safety leader for assigned projects or products. This position will be in Fort Worth, Texas.

Responsibilities:

• Perform medical review of single cases and/or aggregate data involving the assigned product(s).
• Provide safety input to the clinical and regulatory deliverables, including Investigator's Brochures, study protocols, study reports, clinical overviews, and product registrations.
• Monitor the clinical safety of assigned products/projects, including adverse events and patient impact from technical complaints from studies, literature, and post-market surveillance.
• Compile, analyze, and interpret clinical and scientific data from multiple sources; summarize safety trends with supervisory guidance.
• Prepare literature summaries on special topics to characterize product safety profile and support risk management documents.
• Support the preparation and maintenance of post-market surveillance plans, periodic safety updates, product labeling and related documents.
• Support the preparation of health hazard assessments and responses to inquiries from health care authorities, health care professionals, or local affiliates.
• Support business development and licensing activities, health authority inspections/audits, and market action activities.

Minimum Qualifications/Key Requirements

• Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs.; Assoc. +9 yrs.; M.S.+2 yrs.; PhD +0 yrs.)
• The ability to fluently read, write, understand, and communicate in English
• 5 Years of Relevant Experience

Preferred Qualifications:

• Industry experience
• Clinical experience
• Advanced Degree: O.D. preferred