Product Surveillance Reporting Specialist
4 weeks ago
SRG is seeking a Product Surveillance Reporting Analyst to partner with a pharmaceutical organisation in Marlow.
The Reporting Specialist will be responsible for executing all reporting, in partnership with internal and external stakeholders. This includes pharmacovigilance, local in-country teams, and the device quality assurance team.
Key Responsibilities:
- Decision maker for all 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
- Manages regular reporting needs and external requests
- Manages the timeline for end-to-end reporting
- Owns translation services for reporting
Requirements:
- Bachelor's Degree required, 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
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products
- Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations
- Ability to prioritise multiple projects to ensure compliance with regulations and standard operating procedures
- Solid written/verbal communication and organisational 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
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