Patient Safety Lead 587

ProductLife Group is looking for a Patient Safety Lead to join our dynamic team on the following missions :

About us

Group 10
Responsibilities

  • Ensuring compliance to all applicable Global and local PV processes, and regulation
  • Ensuring audit/inspection readiness at all time
  • Supporting the development and implementation of necessary processes, systems and tools for the handling of local PV activities, as per assigned responsibilities
  • Supporting local and global PV strategies, and implementation at LOC level, as per assigned responsibilities
  • Act as SME, as per assigned responsibilities and as it relates to applicable global, local regulatory requirements, resourcing, compliance and other factors
  • Engaging with key local internal stakeholders, including Medical, Regulatory Affairs, Quality Assurance, commercial teams and external stakeholders (vendors, partners) with PV obligations, agreements, etc
  • Establishing appropriate oversight of vendors/suppliers, as required
  • Ensuring collaboration with Global GPSE to best support LOC needs

Group 11
Education & Experience

  • Life science degree (Bachelor’s required. Advanced degree preferred)
  • Advanced experience in pharmacovigilance or related environments required (Min 5-7 years)
  • Advanced experience of working cross-functionally, preferably in R&D companies.
  • Understanding of medical/scientific terminology
  • Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation

 

Group 13
Skills

  • Excellent written/oral communication skills (local language and English) and experience working within virtual teams
  • Leadership skills
  • Excellent collaborative skills
  • Excellent organizational skills
  • High standard of computer literacy
  • Experience in local PSMF activity

Patient Safety Lead 587