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Senior Specialist Pharmacovigilance

Reference:SCAHXQ-053318
Location: Republic of Ireland
Qualification:Degree
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Pharmacovigilance

Senior Specialist Pharmacovigilance-100% remote working
Our client a pharmaceutical consulting organisation are currently recruiting for an Senior Specialist Pharmacovigilance to join their team on a permanent basis. As Senior Specialist Pharmacovigilance you will be accountable for the execution of operational tasks in the field of pharmacovigilance that require specific technical expertise in the field of medicines and medical documentation. This role is 100% remote working. Fluency in German is essential for this role.

Responsibilities

  • Provision of pharmaceutical expertise in the entire field of pharmacovigilance
  • Management of safety-relevant information from all sources (including, but not limited to spontaneous, literature, clinical studies, medical information enquiries)
  • Case processing (data entry), including translation German/English and quality check of translation
  • Data entry quality check (without case assessment)
  • Screening of local scientific literature (safety relevant publications), including creation of search algorithms for local literature screening
  • Performing administrative and operative tasks within the literature surveillance tool such as management of contract and user accounts, upload references and reporting documents into the web system
  • Tracking of the internal literature ordering process
  • Support with creation of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and from the literature; reporting of ICSRs to the competent authorities
  • Documentation of case processing on a company and a case level
  • Support in the generation, processing and tracking of follow-up requests
  • Handling of Customer enquiries or complaints according to quality assurance requirements
  • Assistance in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs, Safety Update Reports), risk management plans and signal detection reports
  • Assist in managing clinical trials
  • Author/review procedural documents such as Working Instructions, SOPs, Working Procedures, templates etc. for pharmacovigilance projects
  • Preparation of and participation in internal and external PV audits/inspections
  • Ensure management of Corrective and Preventive Actions (CAPA) for own processes, including tracking of CAPA status
  • Perform Regulatory/PV Intelligence screens of the applicable sources (e.g. Authority websites) and alignment with (Senior) Manager PV on gap analysis/impact assessment
Requirements
  • Medical Documentation specialist or University degree in Life Science
  • Degree in Life Science or equivalent with proven expertise and experience in GxP and / or pharmacovigilance (GVP) and related aspects
  • 3-5 years of experience in the field of pharmacovigilance
  • Excellent knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
  • Ability to organize operating procedures and to take over project management duties
  • Professional verbal and written communication skills with internal and external clients
  • Fluent in German and English
  • Excellent written and verbal communication skill
For more information contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie



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