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Pharmacovigilance Systems Specialist

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
12 Aug 2019
Closing date
9 Sep 2019

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Job Details

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Systems Specialist.

Objective
To manage the system-level functionality of PV databases and related systems (PV systems) including the safety database, product databases and tracking databases and data extraction from those systems.

Responsibilities
General
•    Delegation of PV systems-related tasks from the PV Systems Manager (PVSM), EU QPPV and the Group Executive on an ad hoc basis.
•    Liaising with IT on issues relating to data extraction and system-level functionality of PV systems including the safety database, product databases and tracking databases.
•    Liaising with PV systems vendors on issues relating to data extraction, systems functionality and user access as well as potential upgrades of those systems.
•    Liaising with PV Quality Management and Compliance Manager (PV QMCM) to document deviations from SOPs relating to PV Systems and providing assistance with generation and implementation of any resulting CAPAs.
•    Review and advise on relevant local & global guidelines, policies, internal procedures and SOPs across company affiliate companies.
Safety Systems Management
•    Database management of the safety database system with assistance from the vendor support team and company Ireland IT department including:
o    Project management of patches and upgrades to the safety database system.
o    Project management of updates to safety database libraries including code lists and coding dictionaries.
•    Management of user access with regards to safety database and ensuring adherence to number of licences acquired.
•    Monitoring of support tickets opened with the vendor to minimise redundancy and determine presence of trends or underlying issues.
•    Coordination of the acquisition and preparation of data for review from all PV systems in order to support the generation of external reports including periodic reports (such as PSUR, PADER and PBRER) and Risk Management Plans (RMPs).
•    Coordination of the acquisition and preparation of data in support of Signal Management (SM), product recalls and other surveillance activities.
•    Support of the Case Workflow Manager in acquisition and preparation of case processing metrics.
•    Management of outsourced data collection with vendors as required.
•    Coordination of data migration activities with partner organisations as required.
•    Management of safety and product data sharing with affiliates.
•    Coordination of searches from safety, product or regulatory databases.
•    Provision of support on preparation of reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
•    Coordination of any data required for the purposes of reconciliation with company departments, affiliates or safety partners.
•    Oversee follow up on data integrity related queries that are raised as a result of reconciliation activities.
•    Liaise with PVSM, PV QMCM and Quality Assurance (QA) department to ensure all changes to the system is managed via change control. 

Product Database Management

•    Database management of the MPD database system with assistance from the vendor support team and Ireland IT department including:
o    Project management of patches and upgrades to the MPD database system.
o    Project management of updates to the Medicinal Product Dictionary (MPD) and the Company Product Dictionary (CPD) including code lists and coding dictionaries.
•    Coordination of triage, data entry, quality control, medical review and final submission of all product data into MPD with assistance from the Case Workflow Manager and the ICSR processing team.
•    Verification of compliance with XEVMPD and IDMP reporting requirements by collecting metrics and overseeing reconciliation with regulator product databases.
•    Support ICSR compliance by ensuring the CPD meets suspect product data requirements.
•    Develop and maintain the company product information (CPD) system with assistance from PV QMCM and ICSR processing team and provide accurate product support.
Training
•    Keeping informed on emerging pharmaceutical industry legislation and data standards. 
•    Training junior associates, new staff and affiliate PV departments in the correct use of PV systems.
Requirements
•    Life sciences/biological sciences graduate.
•    Minimum 3 years’ experience in pharmacovigilance.
•    Competent in database administration.
•    Competent in team leadership.
•    Competent in medical terminology.
•    Strong enterprise application/IT skills.
•    Previous use of modern global safety systems

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.

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
Website

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