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LQPPV Manager

LQPPV Manager

PharmaLexAlgeria (Homebased)
منذ أكثر من 30 يومًا
الوصف الوظيفي

Your Job

  • Set up and manage the local pharmacovigilance system
  • Local Literature Search
  • Local ICSR Management
  • PV Intelligence Screening
  • Local PSMF Maintenance
  • Setting up local Organized Data Collection
  • Local PVA Management
  • Local adaptation and submission of PSUR / RMP
  • Local signal detection
  • Implementation of additional Risk Minimization Measures
  • Reviewing materials relating to local post-authorization safety
  • Integrated first Level Medical Information and PQC Support
  • Participate in PV-relevant audits and inspections
  • Attend regular meetings according to project meeting schedule
  • Provide monthly PV report on status of local PV system in the country / ies
  • Ensure PV training of affiliate employees, service providers and Third Parties

LPPV

  • Act as primary contact for PV for Competent Authority in the Territory, including 24 / 7 availability if legally required.
  • Interface between the EU-QPPV / Global PV team at client and the local regulatory authority
  • Close cooperation with the global PV system of the client as well as related global and local departments and functions
  • Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
  • Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
  • Deputy is assuming responsibility in case of planned or unplanned absence

    • Your Profile

  • University degree in Medicine, Pharmacy or Life Science
  • Several years’ experience and profound knowledge in the field of pharmacovigilance
  • Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance
  • Detailed knowledge of related SOPs (global and local)
  • Participation in all relevant courses of instruction such as internal trainings and applicable external courses
  • Experience in all operative tasks that are performed by the members of the pharmacovigilance department
  • Familiarity with industry principles of pharmacovigilance
  • Ability to organise operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)
  • Ability to adjust rapidly to new, unknown, challenging situations
  • Ability to analyse and solve problems and to develop possible solutions
  • Autonomous, concentrated and high-quality work
  • Ability to work in a team
  • Sense of responsibility
  • Very good command of English