Drug Safety Lead/ Senior Manager

For one of our clients in Switzerland (Zurich area), we are urgently looking for an experienced Drug Safety Lead.

Previous experience in drug safety is required, as well as a fluent knowledge of English and a medical background.

Don't hesitate, and apply as soon as you can!

Responsibilities 
  • Ensuring ICH/FDA/EMA guideline compliance of company drug safety
  • Responsible, in close collaboration with Clinical Operations and Clinical Development, to organize the exchange of all safety relevant information between the Drug Safety Department The Client Pharma and involved CROs for all clinical development projects.
  • Responsible, in close collaboration with Clinical Operations and involved CROs, for the review/preparation of individual safety reports (incl. SUSARs) and reports of aggregated clinical data (Annual Safety Reports/Developmental Safety Update Reports) according to legally required timelines to Health Authorities, Ethical Committees and external Safety Review Boards.
  • Responsible for data unblinding whenever appropriate and data reconciliation of clinical safety data entered into the The Client safety database after finalization of a clinical development project.
  • Support Clinical Development/Regulatory Affairs/Affiliates on ad hoc questions concerning medical / clinical safety (expert reports, regulatory dossiers)
  • Drug Safety Monitoring, Review of signal detection listings and escalating drug safety issues for further investigations in a timely manner
  • Authoring high quality safety relevant texts and periodic drug safety reports
  • Ensuring compliance with regulatory agencies
  • Drug Safety related inputs into study protocols, study reports, informed consent forms and SmPC/Patient Leaflet
  • Involvement in the correct communication and information on drug safety topics, in particular drug safety review of promotional and medical affairs material
  • Drug Safety Training for The Client Pharma staff (initial and continuous)
  • Participation of Emergency phone team
  • Regular reporting to line manager
  • Special duties on assignment
Profile 

Minimum Requirements

  • Medical Degree, ideally Specialist in Internal medicine or Pharmaceutical Medicine or PhD/ Equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety
  • Experience in data analysis, signal detection and benefit/risk evaluation
  • Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)
  • Fluency in English

Preferred Requirements

  • Experience in Pharmaceutical Medicine, particularly Clinical Research, and/or experience in Clinical Pharmacology
  • Knowledge and experience in Pharmacoepidemiology
  • Demonstrated ability to set up and implement Drug Safety strategies, Risk Management Plans, develop Drug Safety systems and procedures, and elevate and resolve issues
  • Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issues.
  • Good computer literacy with experience with safety data bases (Aris G preferably)
  • Capable of exercising oversight in communications and problem solving liaisons with internal and external customers
  • Capable of exercising oversight in the maintaining understanding of Drug Safety issues with Clinical team members and ensure appropriate training through workshops, seminars, courses, literature, or other means consistent with Drug Safety development.
Contact Information 

Nele Daems
nele.daems@valesta.com
015 21 11 04

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