Product Reporting Analyst

3 weeks ago


Marlow Buckinghamshire, United Kingdom SRG Full time

Marlow – hybrid (3 days on site)


SRG are partnered with a pharmaceutical organisation who are seeking a Product Surveillance Reporting Analyst to join their team in Marlow.
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.
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
• 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 (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 and 211) is preferred.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• Knowledge and application of computer systems for word processing and complaint management.



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