Browse by job sector

Senior Pharmacovigilance Manager

  1. Remote
Remote work
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
09-04-2024
33793
Apply to this job Save job
Senior Pharmacovigilance Manager - Remote/UK - 12-Month Contract

We have an exciting opportunity for a Senior Pharmacovigilance Manager to work for a fast-growing global pharmaceutical company with a leading portfolio of innovative treatments. They are focused on critical care and rare diseases and are looking for a Senior Pharmacovigilance Manager for their UK and remote based location.


Responsibilities:
  •  Day to day management of the PV Team.
  • Ongoing monitoring of the safety profile of our clients medicinal products and continuous overall safety evaluation during the post-authorisation period.
  • Oversight of Individual Case Safety Reports (ICSRs), Standards Operating Procedures (SOPs), authoring aggregate reports (PSURs and PADERs) and Safety Data Exchange Agreements (SDEAs).
  • PV SME for Risk Management Plans (RMP), Post Authorization Safety Study (PASS) protocols, Risk Minimisation Strategies, effectiveness of follow-up measures, post-marketing commitment and e-transmissions to competent authorities.
  • Audit/inspection readiness for the PV audits, ensuring successful audit/inspection outcomes and ensuring findings are appropriately addressed and closed timely.
  • Ensuring the 5-year audit plan for pharmacovigilance is executed as planned, maintained on an ongoing basis and ensuring the pharmacovigilance system is fully audited on a rolling 5-year basis.
  • Author or review and sign off aggregate reports (PADERs and PSURs), Risk Management Plans particularly if they relate to drug safety, to assure that quality is maintained and that benefit/risk information is accurate and not misleading.
  • Ensure departmental compliance with EU, US, Canadian and other relevant global pharmacovigilance regulations

Requirements:
  • A medical or Life Science Degree
  • Minimum 5 years experience in the pharmaceutical industry, with solid experience in pharmacovigilance
  • A good understanding of normal and pathological physiological function
  • Experience with product-oriented contact with doctors and patients
  • Experience of managing outsourced activities
  • Proficient in developing and implementing programs and policies
  • Strong exposures of authoring and review and sign off aggregate reports (PADERs and PSURs), Risk Management Plans particularly if they relate to drug safety, to assure that quality is maintained and that benefit/risk information is accurate and not misleading.

 If this role is of interest to you, please apply now! 

 #LI-KT1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Vice President of Regulatory Affairs

Salary

Competitive

Location

Remote work

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Permanent

Location

Remote

Description

VP Regulatory Affairs – Remote – Life Sciences  Our client, a prominent consulting and solutions firm specialising in risk management and compliance services for the pharmaceutical industry,

Reference

32892

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more
Expert in Pharmacovigilance

Salary

Competitive

Location

Brussels

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Contract

Location

Brussels

Description

Expert in Pharmacovigilance - Belgium - 13-Months   This is a unique opportunity for an Expert in Pharmacovigilance to join our client – an esteemed partner for regulatory and compliance in

Reference

32169

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more
Regulatory Affairs Expert

Salary

Competitive

Location

Brussels

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Contract

Location

Brussels

Description

Regulatory Affairs Expert in Animal Health – Pharmaceuticals – Brussels – 12 Months  Do you want to be involved with exciting Pharmaceutical projects?  When it comes to the development and

Reference

32170

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