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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