Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Pharmacovigilance Systems Specialist

Company: Thornshaw Recruitment
Location:
Reference: LD9670
Closing Date: 23 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance System Specialist.

Requirements:

Our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance System Specialist.

Role
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.
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.
  • Ensuring Good Documentation Practice.
    Safety Systems Management
  • Database management of the safety database system with assistance from the vendor support team and company 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 company 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. QA sign off is required for system release. 
    Product Database Management
  • Database management of the MPD database system with assistance from the vendor support team and 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.
  • 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

•    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 ARISg database is required.
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

Apply for this job: Pharmacovigilance Systems Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.