Global Safety Lead

This Global Safety Lead opportunity is built around quality Management: Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. It would suit someone who can bring regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety to the role.

What the work leans on

Integrate safety risk management activities of the product into their medical, business, and regulatory context. Serves as the safety representative in the cross-functional development teams and post-marketing product teams.

Care and support involved

• Quality Management: Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards.
• Process-related matters in a complex medical and scientific environment including many interface departments and functions.

Care skills and requirements

• Clinical Safety Representation: Chairs the Safety Management Team (SMT). Represents GSPV in relevant cross functional teams.
• Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
• Two (2) years minimum experience as a physician in patient care.

What helps in this care setting

Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.