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.

Responsibilities

• 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

Requirements

• 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)