Reporting Specialist II

Responsibilities

• Lead for all vigilance reporting, including local and global submissions
• Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate
• Ensures that relevant stakeholders have visibility to the reporting and where they are in the process and effectively communicate throughout
• Manages more complex reporting needs and external requests (i.e. from the FDA)
• Manage the timeline for end to end reporting
• Owns translation services for reporting
• Seeks efficiencies and ways to continuously improve our existing processes
• Provide mentorship to Reporting Specialist I team members

Qualifications

• Bachelors Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background
• 7+ years of work experience in a cGMP related industry or in a clinical setting (preferred)
• In-depth knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products
• Solid written/verbal communication and organizational skills
• Knowledge and application of computer systems for word processing and complaint management
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers