- 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.
- 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
- Ophthalmologist with cataract and/or glaucoma expertise
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