Product Surveillance Reporting Specialist - new job in Marlow, UK

Product Surveillance Reporting Specialist
  • Competitive
    ANNUM
  • Temporary
  • Marlow, Buckinghamshire, England, UK SL6 1EW Marlow Buckinghamshire UK SL6 1EW
Job Ref: J2165597
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 27 July 2022
Reporting Specialist 6 Month Contract - Possibility of extension. Hybrid - Marlow (Remote work possible) Competitive Rate

At SRG we are partnered with Abbvie, a global biopharmaceutical company who are searching for Reporting Specialists to join their growing Product Surveillance team. This is an exciting opportunity for a candidate with a background in Pharmacovigilance or Regulatory and the ability to prioritize multiple projects to take their career to the next step and gain valuable experience at an industry leading organisation. With the possibility of extension or joining the team on a full-time basis at the conclusion of the contract this is a great opportunity to deepen your experience and understanding of the industry.

Purpose:

The Reporting Specialist I 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. They will interface with regulators and serve as the liaison to the respective team when questions and requests arise.

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)
  • Manage the timeline for end to end reporting
  • Owns translation services for reporting

Qualifications:

  • Bachelor's Degree required; preferably in the life sciences, pharmacy, nursing, or other scientific background
  • 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.

If you would like to hear more about this position please apply via the link contained here or send me a copy of your CV to guy.mcdonald@srgtalent.com.

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
26/08/2022 15:47:33
GBP 0.00 0.00 Annum
Contact Consultant:
Guy Mcdonald

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