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Senior Pharmacovigilance Manager

Salary rangeConfidential | Contract type: Permanent

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Job Summary

The Pharmacovigilance Senior Manager provides support to the Global Pharmacovigilance function (based in Switzerland) in relation with clinical studies conducted and/or sponsored by DNDi (conducted in Africa, Latin America, Asia, India, and other regions) and overall drug safety/pharmacovigilance expertise, and contributes to the development and registration of new treatments for neglected diseases.
S/he oversees clinical safety activities on studies/programmes assigned to her/him

Responsibilities

S/he will be responsible for the following clinical safety activities, primarily (but not exclusively) concerning clinical studies/activities assigned to her/him:
  • Product subject expert within the PV function
  • Subject matter expert in clinical safety data interpretation, clinical safety analysis preparation/benefit/risk assessment within periodic safety update reports (together with product/trial medical responsible and PV function Head), or subject matter expert in signal detection activities, safety risk management activities, and safety profile/safety reference information maintenance
  • Subject matter expert in interpretation of regulatory aspects of clinical safety/pharmacovigilance
  • Assist the function Head in training and mentoring PV team colleagues including on interpretation of clinical safety data and analysis preparation and safety risk management activities
  • Assist the function Head in overall activity planning and budget preparation
  • Medical review performance and contribution to serious adverse events/other Individual Case Safety Reports (ICSRs) narratives preparation and assessment, together with other PV team members and with contribution (as necessary) of the clinical team members
  • Preparation of study-specific safety management plans (SMP; defining roles and responsibilities of each party involved in clinical safety data flow/ processes, templates, and timelines; using SMP template)
  • Review of safety cases line listing (LL) and periodic safety reports (i.e. DSUR or local formats) and contribution to study-specific periodic progress reports
  • Contribution to study -specific PV training materials and safety-related sections of study documents together with other PV team members and in collaboration with clinical team members
  • Contribution to the preparation/update of PV standard operating procedures, working instructions, and templates
  • Support the global PV function in ensuring that all PV-related activities related to the management of DNDi-sponsored clinical studies are performed by trained personnel and compliant with applicable local/international safety reporting requirements
  • Regular collaboration with other PV team members and PV-services providers, Clinical Research Organizations (CROs), DNDi regional offices, and central clinical programme leadership
  • Contribution to other DNDi functions from a drug safety perspective

Job Requirements

Required education: Bachelor's degree
Required relevant work experience: 7 years
Required languages: English (Spoken: fluent | Written: fluent)
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