Reporting Specialist II

The Reporting Specialist II is responsible for executing all reporting, partnering with internal and external stakeholders. Partners with pharmacovigilance, local in-country teams, and device quality assurance to ensure appropriate and accurate complaint reporting. Interfaces with regulators and serves as liaison when questions/requests arise. Manages more complex reporting needs as a subject matter expert, and provides mentorship/support to Reporting Specialist I.

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 communicate throughout
- Manage complex reporting needs and external requests (e.g., FDA)
- Manage end-to-end reporting timelines
- Own translation services for reporting
- Seek efficiencies and continuously improve existing processes
- Provide mentorship to Reporting Specialist I team members

Qualifications:
- Bachelor’s degree strongly preferred (life sciences, pharmacy, nursing, or other scientific background)
- 7+ 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
- In-depth knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, 211) preferred
- Ability to prioritize multiple projects to ensure compliance with regulations and SOPs preferred
- Solid written/verbal communication and organizational skills
- Knowledge/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