Reporting Specialist II
About The Position
The Reporting Specialist II is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. They will interface with regulators and serve as the liaison to the respective team when questions and requests arise. They will also manage through more complex reporting needs and are expected to be a subject matter expert. The individual will provide mentorship and support to the Reporting Specialist I team members.
Requirements
- 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.
Nice To Haves
- Bachelor’s 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 FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
Responsibilities
- Decision maker for reportability decisions
- 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
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
