Senior Drug Safety & PV Associate

About this role

Responsibilities

• Draft or review documents produced for regulatory agency safety inquiries for scientific content and alignment with company position, clarity, accuracy, and consistency
• Participate in ongoing safety data review and analysis for assigned products and ICSR case management, as well as maintenance of safety database and creation of processes involving handling case reports within the safety database
• Interface with other Insmed functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed
• Contribute to on-going process enhancement for safety operations such as developing standard procedures and templates, and the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the PV activities
• Participate in internal global PV meetings as well as joint safety meetings with partners if needed