Job description

Job: Drug Safety Specialist – Fixed term

Department: Research & Development – Drug Safety Unit

Direct Report: Deputy EU QPPV

Interfunctional Cooperation: Regulatory Affairs, Marketing, Business Development

Duties and Responsibilities:

  • Review the worldwide reports on adverse events to perform reporting to Competent Authorities, calculate KPI, and prepare safety reports
  • Prepare aggregate safety reports (i.e. signal detection, PSURs)
  • Revision of safety section of Company product RSI
  • Support the DSU in the performance of safety training for new employees
  • Risk Management Plans preparation/revision etc.
  • Revision/writing Company SOPs
  • Support the DSU in the maintenance of Company PSMF
  • Negotiation of SDEA with business partners and/or Third parties Providers
  • Monitoring of activities delegated to external Providers
  • Ensure safety tasks in clinical trials (incl. protocol review, safety management plan, AE/SAR/SUSAR management, safety reporting) are handled appropriately and in compliance with regulations and applicable agreement in place with CRO and/or Providers
  • Participates in project specific teleconferences/meetings as required
    Participates in project specific teleconferences/meetings as required


Profile

Experience: minimum 3 years’ experience in Pharmacovigilance field (post-marketing and pre-marketing)

Education: Bachelor’s or Master’s Degree in scientific or Healthcare Area (Pharmacy, Chemical and Pharmaceutical technology, Biology)

Hard Skills:

  • Fluent English
  • Experience in data analysis, signal detection and benefit/risk evaluation
  • Good knowledge of International Regulations (ICH, GVP, PV extra EU-regulations is a must)
  • Ability to set up and implement Drug Safety strategies, risk management plans, develop Drug Safety systems and procedures, elevate and resolve issues
  • Good knowledge of pharmacovigilance and medical terminology

Soft Skills:

  • Accountability
  • Communication skills
  • Flexibility
  • Excellent attention to detail and accuracy
  • Analytical and critical thinking
  • Organization and time-management

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