Senior Medical Safety Advisor
Warsaw, Poland
6 d. temu

Role & Responsibility

  • Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions;
  • ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary

  • Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
  • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
  • Ensure service delivery from productivity, compliance and quality perspective within regulatory / contracted timelines.
  • Lead and participate in the initiatives taken for the same from team delivery perspective

  • Provide therapeutic area / pharmacovigilance issue guidance in the context of leading / managing other safety team members in single case assessment.
  • Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
  • Maintain awareness of medical safety-regulatory industry developments
  • Qualification (Essential)

  • Physician's license (exclude Chinese traditional medicine)
  • Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate and / or Residency training can qualify for clinical practice experience
  • English language proficiency in reading and writing (e-learning programs will be provided in English)
  • Qualification (Nice to have) :

  • Sound knowledge of Medicine
  • In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Knowledge of Pharmacovigilance - ICSR and Aggregate reports
  • Any experience in clinical trials and pharmacovigilance.
  • Adequate Computer skills, especially Microsoft word, excel & PowerPoint
  • Good communication skills- verbal and written
  • Ability to establish and maintain effective working relationships with managers, co-workers, investigativesite staff, clients and regulatory agency representatives
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Location : Homebased

    Workstyle Options :

  • Full-time (7.5 hours / day)
  • Part-time (At least consecutive 3 hours / day
  • 3 days / week 9 hours / week as minimum)
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