Senior Drug Safety Physician (Bilingual French - English)
Drugs for Neglected Diseases initiative (DNDi)
- Nairobi
- Permanent
- Full-time
- The Senior Drug Safety Physician provides support to the Global Drug Safety and Pharmacovigilance (DSPV) 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.
- This role oversees clinical safety activities on studies/programs assigned to the Senior Drug Safety Physician and provide medical expertise to the DSPV team.
- Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
- Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies.
- Very strong communication skills in multicultural, multi-lingual environments.
- Over 10 years in Senior role
- Proven ability to work effectively in a team environment and matrix structure.
- Experience of working in public and private sector is highly desirable.
- Proven track record in as drug safety physicians contributing to drug safety, pharmacovigilance.
- Excellent knowledge of Pharmacovigilance (pre- and post-marketing) and Clinical Research/Development
- Excellent knowledge of Regulatory (GCP, GLP and GMP)
- Medical doctor
- Fluency in French and English a must
- Proficiency in other languages an advantage (Spanish, Portuguese...)
- Good knowledge of Microsoft Suite
- One year full-time employment contract, renewable
- Location: UK or Germany (remote) or one of these DNDi office locations (hybrid): Brazil, Democratic Republic of the Congo, India, Japan, Kenya, Malaysia, South Africa
- Support the Head of Drug Safety and Pharmacovigilance (DSPV) in ensuring that all Pharmacovigilance -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
- Bring medical expertise to drug safety activities for assigned trials and products.
- Provide support for Drug Safety Scientists (non-medically trained) and other Drug Safety Physicians in the DSPV team
- Assist the function Head in training and mentoring DSPV team colleagues including on interpretation of clinical safety data and analysis preparation and safety risk management activities
- 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 DSPV 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
- Regular collaboration with other DSPV team members and Pharmacovigilance services providers, Clinical Research Organizations (CROs), DNDi regional offices and Disease/clinical program leadership
- Coordinate the Product Safety Monitoring Sub-Team (PSMT) related to assigned product(s)/projects.
- Coordinate the signal management activities, development risk management activities related to assigned product(s) in collaboration with clinical team/PSMT members and as necessary, other PV team members.
- Coordinate the preparation of development Risk Management Plan (dRMP) and evaluation of safety data and benefit-risk assessment in collaboration with clinical team/PSMT members and as necessary, other PV team members.
- Propose Pharmacovigilance / Risk management (PV/RM) activities for important identified and potential risks to the PSMT and DNDi Drug Safety Committee (DSC).
- Contribute to the maintenance and update of safety profile information and safety reference documents related to product(s) assigned to the incumbent in collaboration with clinical team/PSMT members and as necessary, other DSPV team members or partners.
- Contribute to marketing authorization registration dossier from a drug safety perspective.
- Coordinate serious adverse events/other Individual Case Safety Reports (ICSRs) medical review and assessment for assigned trials and as per Safety Management plans.
- Ensure the availability and approve study-specific safety management plans and SAE reconciliation plans for the assigned trials, prepared by the PV Service Provider.
- Review of safety cases line listing (LL) and preparation/review of periodic safety reports (i.e. DSUR) 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 DSPV team members and in collaboration with clinical team members.
- Support the DS Product/Project Responsible on drug safety activities related to the product: contribution to evaluation of safety data, benefit-risk assessment and dRMP preparation and proposals for PV /risk minimization activities.
- Contribution to the preparation/update of PV standard operating procedures, working instructions and templates.
- Support the global DSPV function in ensuring that all drug safety-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 DSPV team members and PV-services providers, Clinical Research Organizations (CROs), DNDi regional offices and Central clinical program leadership.
- Contribution to other DNDi functions from a drug safety perspective.
- The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade.
- Head of Drug Safety and Pharmacovigilance based in Geneva, Switzerland
- Works with clinical teams/program teams, and potentially all units in the R&D department involved in assigned trials/programs.
- Works with the DNDi global PV services provider, DSPV Intervenors and concerned Clinical Research Organizations.
- This role promotes programs and maintains productive relationships by projecting the image of a credible partner and ensures commitment of partners.
Fuzu