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PV Systems Associate

Ref: 9217838

  • €27,500 - €30,000
  • 17 Jun 2019
  • Dublin (West)
  • Perm

Brightwater is delighted to retained in the search for an PV System associate To assist in management of the system-level functionality of PV databases and related systems (PV systems) including the safety database, product databases and tracking databases and supports data extraction from those systems according to business needs.

General;

• Delegation of PV systems-related tasks from the PVSS, QPPV and the Group Executive on an ad hoc basis • Liaising with APTL IT and PV systems vendors on issues relating to data extraction, systems functionality and user access • Ensuring Good Documentation Practice • Adherence to company health & safety procedures

PV Systems Management:

• Assist, where necessary, the PVSS in management of PV systems in coordination with vendor support teams and APTL IT department. The PVSA may assist with: o Patches and upgrades to the safety database system o Updates to safety database libraries including code lists and coding dictionaries • Assist the PVSS in management of data migration activities with partner organisations as required • Processing of PV system user access requests • Tracking of SLA reports and support tickets opened with system vendors to minimise redundancy and determine presence of trends or underlying issues • Retrieval of data from PV systems in order to support the generation of internal reports (such as the monthly QPPV report) and external reports including periodic • Coordination of the acquisition and preparation of data in support of Signal Management (SM), product recalls and other surveillance activities • Support of the ICSR team in acquisition and preparation of case processing metrics • Support the provision of any data required for the purposes of reconciliation with all departments, affiliates or safety partners • Coordination of the product data (XEVMPD, IDMP, CPD) submission workflow under the direction of the PVSS and with assistance from the PV CWM and the ICSR processing team • Verification of compliance with product data submission requirements by collecting 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 • Tracking and archiving of documentation relating to PV systems • Support other Group PV initiatives as directed by the PVSS and EU QPPV

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 • Maintain a high and up-to-date level of product and therapy area knowledge by attending conferences

Personal Profile:

• Excellent oral and written English communication • Detail oriented, solutions provider with the ability to multi-task and work with a high degree of accuracy • Highly organized and flexible • Manage evolving deadlines effectively with regular feedback and updates • Above average computer skills • Occasional travel may form part of the job • Respectful and highly personable • Possess cultural awareness and sensitivity • Flexibility & Confidentiality are key requirements for this role • Enthusiasm and drive to take ownership and drive process initiatives

Requirements:

• Life sciences/biological sciences graduate • Minimum 1 years’ experience in regulatory, pharmacovigilance or clinical data management • Strong enterprise application/IT skills • Previous use of current generation safety database or clinical trial databases is required To apply for this PV System associate role, click the “Apply Now” button or for more information, please contact Marc Bentley on 01 662 1000 or email m.bentley@brightwater.ie