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Pharmacovigilance Scientist

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Neg
Start date
6 Dec 2022
Closing date
12 Dec 2022

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Discipline
Clinical Research, Pharmacovigilance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

On behalf of our client, a Dublin based pharmaceutical company, we are currently recruiting for a Pharmacovigilance Scientist. There are hybrid and flexible options available.   This role reports to the Head of Pharmacovigilance/QPPV.

 

The Role: support the Head of Pharmacovigilance / QPPV to ensure that the Pharmacovigilance system is compliant with applicable EU regulatory requirements, including but not limited to the performance of the following activities:

 

  • Signal detection management Risk Management plans Aggregate Safety Reports CCDS Management / Clinical Safety

Key Responsibilities:

 

The main responsibilities are detailed below, the Head of Global PV/QPPV may assign additional responsibilities based on the need of the Global PV department. The PV Scientist will work closely with the other PV Scientist to achieve the following at a minimum

 

Perform the signal detection activities as per the schedule defined in Company Healthcare procedure, keep track on all activities and document all outputs produced as part of the signal detection activities. Ensure all potential signals/new safety concerns are reviewed and assessed by the relevant stakeholders, as per the applicable procedure and coordinate/document the resulting actions.

 

Contribute/Coordinate/Perform RMPs updates as per the applicable requirements and internal procedure, define risk minimization measures together with the relevant stakeholders and ensure timely implementation, execution, and tracking. Maintain the up-to-date status of all RMPs, manage Regulatory Affairs’ request related to RMPs updates/submissions

 

Contribute/Coordinate Aggregate Safety Reports preparation by Healthcare service provider as per the applicable requirements and internal procedure. Ensure aggregate safety reports quality, on-time submission to the Competent Authorities, Partners & Affiliates, and documentation.

 

Support the Global PV team in ensuring all CCDS are up-to-date and maintained/reviewed as per the applicable procedure. Coordinate the CCDS review by the internal stakeholders and support with the impact assessment on SmPCs/PILs.

 

Academic qualifications & relevant experience required:

 

  • Degree in Life Sciences Minimum 5 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization. Understands and maintains strong working knowledge of PV global regulations and guidelines with PV operational knowledge. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Ability to establish working relationships with people globally and locally, in various functions with a wide variety of disciplines and backgrounds.

For full job spec and details related to this role & company please email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701/087 6811990. 

 

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

 

 

 

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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