Reporting Specialist I

Reporting Specialist I — responsible for executing reporting in partnership with internal and external stakeholders.

Responsibilities:
- Decision maker for reportability decisions
- Lead for all vigilance reporting, including local and global submissions
- Partner with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions; escalate requests as appropriate
- Ensure stakeholders have visibility into reporting status and process stage
- Manage regular reporting needs and external requests (e.g., from the FDA)
- Manage end-to-end reporting timelines
- Own translation services for reporting

Candidate must be onsite in Tempe, AZ in a hybrid schedule: Tuesday–Thursday.

Qualifications:
- Bachelor’s Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background
- 5+ years of work experience in a cGMP-related industry or in a clinical setting (preferred)
- Knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products
- Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, 211) is preferred
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures (preferred)
- 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 interact effectively with peers, management, and customers