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Marlow, United Kingdom SRG Full timeJob Description Product Surveillance Reporting Analyst 6 months £17.96 p/h 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. Purpose of the role The Reporting Specialist is responsible for executing all of the reporting, in...
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Marlow, United Kingdom SRG Full timeProduct Surveillance Reporting Analyst6 months£17.96 p/hMarlow – 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.Purpose of the roleThe Reporting Specialist is responsible for executing all of the reporting, in partnership with internal and...
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Marlow, United Kingdom SRG Full timeSRG are partnered with a pharmaceutical organisation who are seeking a Product Surveillance Reporting Analyst to support their team in Marlow.The Reporting Specialist will be responsible for executing all reporting in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local...
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Product Surveillance Reporting Specialist
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Marlow, United Kingdom SRG Full timeJob Description:The Reporting Specialist will be responsible for executing all reporting in partnership with internal and external stakeholders. This includes leading vigilance reporting, including local and global submissions, and partnering with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalations.Key...
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Product Surveillance Reporting Analyst
1 month ago
Product Surveillance Reporting Analyst 6 months £17.96 p/h 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. Purpose of the role The Reporting Specialist 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. 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 (i.e. from the FDA etc.) Manage the timeline for end-to-end reporting Owns translation services for reporting Qualifications/experience: 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. 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. Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy