Browse by job sector

Regulatory Operations Manager

  1. Home Counties
Hertfordshire
  1. Permanent
£70000 - £85000 per annum
  1. Drug Safety / Pharmacovigilance
02-03-2023
25517

This vacancy has now expired

Regulatory Operations Manager - Permanent - Hertfordshire

Are feeling the need for a change? Is your current Regulatory position not quite hitting the spot and are now realising you are in need of a new focus and direction?

My client based in the Southeast is now looking for an experienced Regulatory Operations Manager within  

We are looking for candidates with extensive experience of XEVMPD data management, submissions and related communication with teams and health authorities. 

Regulatory Operations Manager Responsibilities:
  • Lead the Operations team responsible for Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)
  • (Article 57) submissions to ensure compliance with current regulations
  • Respond to Health Authority queries on xEVMPD data as required and reconcile xEVMPD data with the Affiliates
  • Provide expertise during xEVMPD audits/inspections and support the process by providing reports and
  • Generate, monitor and ensure adherence to compliance metrics and Key Performance Indicators. Provide
  • Reports to senior leadership/stakeholders and escalate issues as needed.
  • Coordinate Annual PV Fee Advice Note review with EEA Affiliates, ensuring any corrective actions have been
  • Made in the xEVMPD database as instructed by the Affiliates.
  • Manage xEVMPD data requests. Generate the reports, analyze the data and distribute to appropriate
We are offering a very competitive salary and benefits package for this new and exciting opportunity.

If this Regulatory Operations Manager position is of interest to you - get in touch!

The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website
Save as a job alert
List #1

Similar Jobs

Regulatory Affairs Specialist

Salary

Competitive

Location

Central London

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Permanent

Location

London

Description

Regulatory Affairs Specialist - London - 12-Month Contract  Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this

Reference

33886

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more
Senior Pharmacovigilance Manager

Salary

Competitive

Location

Hertfordshire

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Permanent

Location

South East

Description

Senior Pharmacovigilance Manager – Biopharmaceuticals - Hertfordshire / Remote Our client, a global biopharmaceutical company with plants across Europe and North America is looking for a Senior

Reference

31656

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more
Clinical Safety Manager

Salary

Competitive

Location

Remote work

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Permanent

Location

Remote

Description

Clinical Safety Manager – Life Sciences – Permanent – Remote (UK or Europe) Our client, a prominent consulting and solutions firm specialising in risk management and compliance services for

Reference

31473

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more

Insights

Picture of a pill with safety written on it

How has pharmacovigilance changed since the COVID-19 pandemic?
Read more

06/29/2022

stethoscope and colourful pills on a yellow background

5 reasons you should work in drug safety and pharmacovigilance
Read more

06/04/2021

What is drug safety and pharmacovigilance?
Read more

05/13/2020

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV