Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five publicly-funded research organizations – Malaysian Ministry of Health, Kenya Medical Research Institute, Indian Council of Medical Research, Oswaldo Cruz Foundation Brazil, and the Institut Pasteur – as well as an international humanitarian organization, Médecins Sans Frontières. The UNICEF/UNDP/World Bank/WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) is a permanent observer. With a robust portfolio, DNDi aims to develop new, improved, and field-relevant drugs for neglected diseases, including leishmaniasis, human African trypanosomiasis (sleeping sickness), Chagas disease, malaria, filarial diseases, paediatric HIV, mycetoma, and hepatitis C that afflict the poorest populations of the world.
Purpose of the position
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.
Specific job 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
Reporting line
- S/he has a primary reporting line to the Head of Pharmacovigilance based in Geneva, Switzerland
- S/he has a secondary reporting line to the Regional Clinical Operations Head, if based in Nairobi
Job requirements
Skills and attributes
- Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Very strong ability to review many documents in a short time frame while maintaining consistency and solid attention to details
- 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
R&D technical skills
- Excellent understanding of clinical safety regulations and processes
- Excellent understanding of drug development, clinical process, and Good Clinical Practices, including in the EU and USA
- 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
Experience
- 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
Education
- Medical Doctor Degree
Other requirements
- Fluency in English
- Proficiency in French and/or Spanish 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
- Experience in HIV, HCV and/or tropical/infectious diseases would be welcome
- Status: full time – permanent contract
Other information
- Status: full time – permanent role
- For Kenya based contract: Work from DNDi Nairobi office, work permit for Kenya preferred but can be obtained for African nationalities
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