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Pharmacovigilance Systems Manager

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
9 Apr 2019
Closing date
9 May 2019

Job Details

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

To manage the PV Systems Team and facilitate system-level functionality of PV databases and related systems (PV systems) including the safety database, product databases and tracking databases. To support data entry to and data extraction from those systems.

Job Duties
•    Delegation of PV systems-related tasks from the QPPV and the Group Executive on an ad hoc basis.
•    Overseeing the management of 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
•    Liaise with PV Science and PV Case Workflow teams to support ICSR and periodic report compliance.
Team Leadership and Strategy
•    Liaising with IT on information system strategy and development for the PV department
•    Leading initiatives with the intention of building more efficient integration between PV systems and systems across all relevant departments and affiliates.
•    Review and advise on relevant local & global guidelines, policies, internal procedures and SOPs across company affiliate companies.
Line Management
•    Day to day line management of all PV Systems Specialists (PVSS) and PV Systems Associates, including:
o    Management of annual leave and planned absences, sick leave and return to work documentation.
o    Daily workload balancing.
o    Training and development.
o    Feedback, promotion and disciplinary actions, in collaboration with the EU QPPV and the HR department.
•    Annual performance management of all PVSS and PVSA, including:
o    Key performance indicator (KPI) goal setting per company schedule.
o    Key performance assessment (KPA) per company schedule.
•    Ensuring Team adheres to Good Documentation Practices and company health & safety procedures.
Safety Systems Management
•    Maintenance of the PV Systems with assistance from the vendor support team and 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 PV Systems with respect to:
o    User access requests.
o    Licence utilisation.
o    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:
o    Generation of external reports including periodic reports (such as PSUR, PADER and PBRER) and Risk Management Plans (RMPs).
o    Signal Management (SM), product recalls and other surveillance activities.
o    Metrics and analytics in support of ICSR, Science and Quality Management teams.
o    Reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
•    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.
•    Support PV Project and Process Manager in maintenance of Safety Data Exchange Agreements (SDEAs).
•    Coordination and validation of searches from safety, product or regulatory databases.
•    Coordination provision of any data required for the purposes of reconciliation with departments, affiliates or safety partners.
•    Oversee follow up on data integrity related queries that are raised as a result of reconciliation activities.
•    Liaise with PV QMCM and Quality Assurance (QA) department to ensure all changes to the system are managed via change control. 

Product Database Management
•    Oversight of PVSS product data workflow management.
•    Project management of patches and upgrades to the MPD database system.
•    Project management of updates to the Medicinal Product Dictionary (MPD) and the Company Product Dictionary (CPD) including code lists and coding dictionaries.
•    Verification of compliance with XEVMPD and IDMP reporting requirements by collection of metrics and overseeing reconciliation with regulator product databases.
•    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 (PVSS and PVSA), new staff and affiliate PV departments in the correct use of PV systems.
Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature.

Requirements
•    Minimum 5 years’ experience in pharmacovigilance.
•    Minimum 2 years’ experience in PV Systems
•    Competent in team leadership.
•    Competent in medical terminology.
•    Strong enterprise application/IT skills.
•    Minimum of 2 years’ experience in admin-level operation of a 5th generation safety database or greater (ARISg 5.x, Argus 5.x or a contemporary system)
•    Excellent oral and written English communication

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
Website

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