The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases that affect millions of the world’s poorest people.
Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.
Since our inception, DNDi has delivered 12 new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 15-18 new treatments by 2028 – addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as Covid-19) and climate-sensitive diseases (such as dengue) with a focus on the needs of patients in low- and middle-income countries.
With 250 employees of 37 nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply.
The R&D organization drive therapeutic innovation from the lab bench to the patient bedside. it develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICS clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDi functions, beyond R&D.
The R&D organization include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Medical Affairs (Pharmacovigilance, Clinical Quality and Assurance, Regulatory and Translational Sciences), Global Clinical Operations, R&D Portfolio and Planning, Discovery and Pharmaceutical Development teams complement the R&D expertise . Projects review, Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organization for all other topics.
The Senior Drug Safety Physician 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.
This role oversees clinical safety activities on studies/programmes assigned to the Senior Drug Safety Physician and provide medical expertise to the PV team.
The Senior Drug Safety Physician is accountable for managing projects, or delivering quality output through expert services or people. This role adapts policies, approaches and models to emerging needs and define practice and procedures/guidelines. This role is accountable of delivery of a complex project within established framework.
Scope of work (results)
This role affects the performance of assigned projects and team and impact on larger programmes.
Specific job responsibilities
The Senior Drug Safety Physician will be responsible for the following clinical safety activities, primarily (but not exclusively) concerning clinical studies/activities assigned to her/him:
- Support the Head of Pharmacovigilance (PV) 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 the trials and products assigned to this role.
- Provide support for Drug Safety Scientists (non-medically trained) and other Drug Safety Physicians in the PV team
- 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
- 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
- Regular collaboration with other Pharmacovigilance team members and Pharmacovigilance services providers, Clinical Research Organizations (CROs), DNDi regional offices and Disease/clinical programme leadership
- Act as Pharmacovigilance Product/Project Responsible (PV PR) for assigned product/project (s):
- Coordinates the Product Safety Monitoring Sub-Team (PSMT) related to assigned product(s)/projects.
- Coordinates 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.
- Coordinates 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
- Proposes Pharmacovigilance / Risk management (PV/RM) activities for important identified and potential risks to the PSMT and DNDi Drug Safety Committee (DSC).
- Contributes to the maintenance and update of safety profile information and safety reference documents related to product(s) assigned to her/him in collaboration with clinical team/PSMT members and as necessary, other PV team members or partners.
- Contribute to marketing authorization registration dossier from a drug safety perspective
- Act as CT Clinical Trial PV Representative(s) (CT PVR) for assigned clinical trials:
- Coordinate serious adverse events/other Individual Case Safety Reports (ICSRs) medical review and assessment for assigned trials and as per Safety Management plans.
- Preparation of study-specific safety management plans for the assigned trials.
- 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 PV team members and in collaboration with clinical team members
- Supports the PV 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 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
The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade. This job description may be subject to review.
- The Senior Drug Safety Physician has a primary reporting line to the Head of Pharmacovigilance based in Geneva, Switzerland
- Works with clinical teams/programme teams, and potentially all units in the R&D department involved in assigned trials/programmes.
- Works with DNDi’s global PV services provider, PV consultants and concerned Clinical Research Organizations
- This role promotes programmes and maintains productive relationships by projecting the image of a credible partner and ensures commitment of partners.
Skills and attributes
- 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
- Very strong ability to work effectively as part of a multicultural team
- Very well organized and structured
- Very strong analytical skills
- Very strong ability to lead project delivery
- Very strong ability to manage large size projects with budget management
- Strong strategic thinking and leadership abilities
- Very strong management, negotiation, and advocacy skills
- Very strong ability to exercise high degree of independence to support programme delivery and explore new areas of activities
- Very strong ability to interact with internal and external stakeholders
- Lead and motivate a team for optimum performance, supervising junior staff
- Excellent understanding of clinical safety regulations and processes
- Good understanding of drug development, clinical process and Good Clinical Practices, including in the EU and USA
R&D technical skills
- Good knowledge of Drug Discovery/Development
- Excellent knowledge of Clinical Research/Development
- Excellent knowledge of Regulatory (GCP)
- Excellent knowledge of Disease
- Excellent technical writing skills (procedures, protocols and reports
- Good understanding of marketing authorization process
- Successful experience in training and mentoring drug safety/pharmacovigilance colleagues
- Very good understanding of clinical or medical safety data signal detection, signal analysis and overall safety risk management in the context of clinical development
- Over 8 years in Senior role
- Minimum 8 years' clinical development experience in which at least 6 years’ demonstrated experience working in clinical safety (within pharmaceutical companies, non-profit organizations or services providers)
- Proven ability to work effectively in a team environment and matrix structure
- Experience of working in public and private sector is highly desirable
- Experience in tropical/infectious diseases would be welcome
- Medical Doctor Degree
- Fluency in both French and English are required
- Proficiency in Spanish, Portuguese or other languages would be welcome
- Very good knowledge of Microsoft Word, Excel, PowerPoint
- MedDRA coding and WHO-DD coding knowledge
- Eudravigilance user or XEVMPD certification would be a plus
- Status: Part time (50 to 70%)– consultancy contract
- Please submit your application using the online form
- Deadline for application: Accepting applications until 7 October 2022.
- Application submission for this position may close early if we have enough suitable applicants
- Only shortlisted candidates will be contacted