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Pharmacovigilance Team Leader

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
21 Mar 2019
Closing date
3 Apr 2019

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Job Details

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Case Workflow Manager.


The role of PV Case Workflow Manager provides both line and operational management of the case processing team. Assist in global safety database configuration and maintenance. Represent the ICSR team at departmental management meetings and provide support to other functions as needed.

  • Oversight of the receipt, processing, follow-up and reporting of individual case safety reports (ICSRs) to ensure compliance with company procedures and regulations.
  • Line and Operational Management of the case processing team, which consists of Pharmacovigilance Associates (PVA), Pharmacovigilance Specialists (PVSp) and PV Co-ordinators (PVCo).
  • Establish and monitor Key Performance Indicators (KPIs) for each staff member and ensure that annual reviews take place according to company policies. 
  • Oversight of case processing metrics including timely entry, reporting and quality of ICSRs to ensure compliance key performance indicators (KPIs) are met.
  • Assist PV Quality Management and Compliance Manager (PV QMCM) in identifying / resolving compliance issues.
  • Raise deviations for non-compliance to case processing SOPs, regulations or guidelines and implement Corrective and Preventive Actions (CAPAs) where required.
  • Liaising with Regulatory Agencies (RA) / review of RA feedback on case quality and compliance issues.
    •    Maintain up to date awareness of worldwide Regulatory Intelligence in respect of case processing and ensuring adequate SOPs, work instructions or data entry specifications exist that reflect the same.
    •    Creation and maintenance of safety reporting plans by collating reporting requirements globally and oversight of implementation of the same in the Global Safety Database (GSD).
    •    Assist PV systems with safety database configuration updates, testing of reporting rules in Argus and data migrations.
    •    Maintenance of the GSD Data Entry (DE) specifications.
    •    Review of Safety Data Exchange Agreements (SDEAs) in relation to ICSRs.
    •    Communicate with Commercial Partners and Local affiliates to ensure ICSR case processing requirements are aligned.
    •    Review, advise and approve relevant local and global guidelines, policies, Internal Procedures and SOPs across companies.
    •    Support PVAs/PVSp/PVCo’s by performing case processing activities e.g. DE, Quality Control (QC) where required.
    •    Delegation of tasks from the PV manager/Deputy QPPV on ad hoc basis. 
    •    Assist in completing searches of GSD or regulatory databases for ICSRs.
    •    Review/input into post-authorisation safety study protocols and study reports at local and global level.
    •    To review AE listings to identify data issues and safety trends as required.
    •    Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance activities by liaising with the PV manager.
  •  

Requirements
•    Biological/Life Sciences Degree or equivalent.
•    3-5 years’ experience in relevant aspects of Pharmacovigilance.
•    Database entry and manipulation for Argus 
•    Working knowledge of Global PV regulatory requirements for ICSRs 
•    Experience with implementing CAPAs
•    Knowledge of Marketing Authorisation rules and regulations.
•    Working knowledge and familiarity with clinical protocols, clinical study reports.
•    Vendor and partner management liaising with internal/external stakeholders.
•    Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies.
•    Experience working with MedDRA coding dictionary.
•    People management experience is essential 
 

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part 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

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

 

Company info
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