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Product Surveillance Reporting Analyst

Employer
SRG
Location
Buckinghamshire, Marlow
Salary
Up to £17.96 per hour
Closing date
17 Sep 2024
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Sector
Regulatory Affairs
Contract Type
Contract
Hours
Full Time
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Job Details

  • 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.

Company

Every day, we help high-calibre scientists, clinical professionals and engineers of all levels build great careers. We are dedicated to providing the best solutions for the broad-based science community, whether temporary or permanent recruitment, cutting-edge managed solutions, or contract scientific and clinical services through Synergy, our unique CRO.

 

We have established relationships with world-class leaders and small-scale start-ups alike. Our clients value our in-depth regional knowledge developed through our presence across the UK and Europe, and our national exposure that means we offer jobseekers an unrivalled range of career opportunities.

 

 

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