As a Director, Global Medical Safety – Surgical you serve as the medical and scientific safety leader for assigned projects or products. You will be trusted to work on the integration, analysis, and interpretation of safety information from clinical development through post-approval lifecycle. In this role, located in Fort Worth, Texas, a typical day will include:
Responsible for key internal safety documents. Develop and update these documents with new or changes in product safety information. Ensure accurate and high-quality outputs.
Responsible for overall signal detection, monitoring, evaluation, and appropriate management of safety information from relevant line functions, clinical studies, post-marketing experience, literature, and other sources. Lead the Safety Management Team (SMT).
Responsible for post-market surveillance plans, periodic safety updates, product labeling and related documents, including safety information to support product claims.
Responsible for health hazard assessments and responses to inquiries from health authorities, health care professionals, and legal on safety issues. Prepare safety data for health authority review boards.
Provide medical and scientific guidance to local affiliates on safety issues.
Provide medical and scientific input to the clinical development program for assigned projects/brands. This includes input to Data Safety Monitoring Board and Safety Adjudication Committee activities, as required.
Provide integrated safety input into all regulatory documents required during active product development.
Ensure timely communication of safety information to Qualified Person for Pharmacovigilance for applicable product portfolio.
Prepare and present safety issues to Boards and other meetings.
Provide guidance on safety topics, initiate and maintain productive cross-functional collaborations internally with R&D colleagues, business partners, and externally.
Ensure support for business development and licensing activities, regulatory inspections/audits, and market action activities.
Foster an innovative culture, ensuring a collaborative, high performing SMT.
Provide resource coverage and support project activities across therapeutic areas to ensure timely safety deliverables, when needed.
May function as a deputy for Head, Medical Safety and Compliance for assigned activities.
Requirements
Bachelor's Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs;
PhD+6 yrs)
The ability to fluently read, write, understand and communicate in English
10 Years of Proven Experience
6 Years of Proven Leadership
Preferred Qualifications
Ophthalmologist with cataract and/or glaucoma expertise
Seniority level
Director
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Staffing and Recruiting
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