Are you an experienced pharmacovigilance professional looking for a new challenge?
Vifor Pharma has an opportunity for a Head of Signal Management to join their drug safety function. This role can be based in Geneva or Glattbrugg.
Ensuring ICH/FDA/ and EMA Guidelines compliance
Responsible of the whole process of signal detection and management
Responsible, in close collaboration with Drug Safety Lead and Therapy Area Lead, that all tasks relating to Signal detection and management are properly conducted in time
Responsible, in close collaboration with Case Management, that data sources for signal detection are available and robust
Responsible, in close collaboration with any Service Provider that all subcontracted tasks related to Signal management are properly conducted in due time
Acting as key contact point for Signal detection and management
Acting as owner of all procedural documents and ensuring regular review and updates
Participating to Audits/Inspection as company specialist of Signal detection and management
Collaborating with Drug Safety Leads/Therapeutic Area Leads for the implementation and improvement of the process
Collaborating with Head Clinical Drug Safety for Signal management in clinical safety data sets
Collaborating with Medical Writing Unit for aggregate safety reports writing
Medical evaluation of adverse event reports
Acting as QPPV for Switzerland as per Drug Authorization Ordinance and Ordinance on Medicinal Products
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, Volume 9A/10, EMA GvP ,FDA regulations and Swiss regulations)
Fluency in English
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)