Get ready for the world after CovidFix your profile
Guest vertical phone smallest
Why Fuzu? Join Fuzu to accelerate your professional growth, meet like-minded people and learn from the best.
Get Started

Senior Pharmacovigilance Manager

Salary rangeConfidential | Contract type: Permanent

You have 2 days left to apply for this job.

Share this job

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


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)
Share this job

Drugs for Neglected Diseases initiative (DNDi) has no other jobs

Similar Jobs

Critical Care Nurse (ICU & HDU)
Nairobi / Aga Khan Hospitals
Chief Radiologist
Nairobi / Summit Recruitment & Search
Inspection Officer Health
Kampala / Insurance Regulatory Authority of Uganda (IRA)
Medical Officers
Nairobi / Kenyatta University Teaching, Referral and Research Hospital (KUTRRH)
Critical Care Nursing Officers
Nairobi / Kenyatta University Teaching, Referral and Research Hospital (KUTRRH)
Improve your chances with Fuzu