Product Reporting Specialist

2 weeks ago


Marlow Buckinghamshire, United Kingdom SRG Full time £18
Product Reporting Specialist

SRG is partnering with a pharmaceutical organisation to fill a Product Surveillance Reporting Analyst position in Marlow.

The successful candidate will collaborate with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure accurate and compliant reporting of complaints.

Key responsibilities include leading vigilance reporting, including local and global submissions, and partnering with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalations.

Requirements include a Bachelor's Degree in a life science, pharmacy, nursing, or other scientific background, and 5+ years of experience in a cGMP related industry or clinical setting.

Preferred skills include knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products, as well as FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations.

The ideal candidate will be able to prioritise multiple projects to ensure compliance with regulations and standard operating procedures, and have knowledge and application of computer systems for word processing and complaint management.

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