Pharmacovigilance Specialist

Pharmacovigilance Specialist

AbbVie

Vienna, Austria

Job Description

  • Ensures a local tracking system is in place, to ensure timely submissions of adverse events to AbbVie Global Pharmacovigilance (GPV), and of ICSRs and Periodic Reports to the Regulatory Authority;
  • Reports monthly compliance metrics and information to GPV or R&D QA PV Compliance within the required timelines;
  • Co-ordinates Affiliate review and submission of periodic safety reports in collaboration with the regulatory department;
  • Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies;
  • Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events and other safety information reportable to GPV from spontaneous and solicited sources and SAEs from clinical studies;
  • Ensures comprehensive data collection and follow-up (e.g. lot/batch #, age or age group, medically relevant information) for all case types including Post-Marketing Observational Studies (PMOS);
  • Ensures local language medical or scientific literature, not included in GPV global literature review, are reviewed to identify possible adverse events or special situations reportable to GPV, and that any reports are forwarded in a timely manner to GPV;
  • Ensures product complaints are reviewed for adverse events, and forwards any AEs identified to GPV;
  • Completes reconciliation between Quality Assurance (QA) and PV at the Affiliate, ensuring that all ICSRs have been identified;
  • Maintains a version-controlled training matrix/plan for local PV personnel which includes but is not limited to Local SOPs, Local Regulations and references to the Global Affiliate PV Modules in ISOTrain;
  • Ensures training compliance with Global and Local PV training requirements in ISOTrain and other mandatory training as required by GPV AVE;
  • Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis; that appropriate training records are maintained and compliance metrics related to this training is reported;
  • Ensures that any training of partner company staff is completed according to local contract requirements, and appropriately documented.

Qualifications

  • Medical, pharmacy or life-sciences degree (or equivalent);
  • Fluency in written and oral German is a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory Authority;
  • Experience working in the pharmaceutical industry in a drug safety role is preferred;
  • Fluency in written and oral English is highly desirable in order to facilitate communications with Global Pharmacovigilance, Regional Medical and other headquarters functions;
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity;
  • Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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