Product Surveillance Reporting Specialist

4 weeks ago


Marlow, United Kingdom SRG Full time
Job Description

SRG is seeking a Product Surveillance Reporting Analyst to partner with a pharmaceutical organisation in Marlow.

The Reporting Specialist will be responsible for executing all reporting, in partnership with internal and external stakeholders. This includes pharmacovigilance, local in-country teams, and the device quality assurance team.

Key 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
  • Manages the timeline for end-to-end reporting
  • Owns translation services for reporting

Requirements:

  • 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
  • Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products
  • Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations
  • Ability to prioritise multiple projects to ensure compliance with regulations and standard operating procedures
  • Solid written/verbal communication and organisational 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


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