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  • Posted: Jul 22, 2020
    Deadline: Aug 28, 2020
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  • 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 internati...
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    Clinical Quality Assurance Manager

    Purpose of the position

    The Clinical Quality Assurance (CQA) Manager supports the Clinical Quality Management System to ensure:

    • Compliance of R&D staff with regulatory and company Ethical and Good Clinical Practice requirements
    • Patient safety and data integrity are respected
    • Risks are identified, investigated, corrected, and communicated to the CQA Leader for escalation to Senior Management if necessary
    • The clinical staff, trials, and sites are inspection-ready at all times

    Specific job responsibilities

    Quality documents (QDs)

    • Support the implementation of a practical, user-friendly, compliant system for the management of the DNDi Clinical QDs
    • Support the overall life-cycle management of Clinical QDs (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement)
    • Support development of QDs for the CQA function
    • Review all other Clinical QDs for compliance with regulations, company policies, other QDs
    • Ensure availability of current QDs to all DNDi staff on an electronic platform
    • Provide controlled copies to external parties
    • Support gap analyses of processes
    • Support process improvement and QD optimization activities

    Training

    • Support company approach for staff training by providing or coordinating training (eg. GCP, QA, Risk Management, QDs)
    • Support maintenance of system to ensure availability of clinical staff training records (CVs, JDs, training logs & records)

    Clinical trial support & optimisation

    • Replace CQA Leader or Senior CQA Manager at Extended Disease Team meetings when needed
    • Be an ad hoc member of Trial teams, attend meetings as needed, and review meeting minutes
    • Attend other meetings as required, in line with need/internal procedures
    • Act as GCP expert/consultant and provide expertise, support, and/or respond to questions from R&D staff on GCP/QA questions
    • Provide support with interpretation of regulatory guidelines
    • Support CQA Leader input to QA section of Clinical Development Plans, where applicable
    • Identify potential risks in trial management activities and communicate these to the trial responsible and CQA Leader

    Audits/quality control

    • Provide input to Audit Plan from discussions/feedback with Trial teams
    • Support management of out-sourced audit activities, including liaison with auditee and DNDi contact, review of draft audit reports
    • Liaise with auditee for the completion of a Corrective/Preventive Action Plan (CAPA plan) and oversee follow-up and timely close-out of CAPA
    • Feed information into the tracking tool to be able to provide trends on audits and audit findings
    • Perform quality control reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures, and others if requested)

    Inspections (or external audits)

    • Support inspection preparation activities and may be called upon to remain with inspector(s) during inspection
    • Provide support to develop and feedback on the inspection CAPA
    • Feed information into the tracking tool for trends on audits and audit findings

    Risk management

    • Follow and maintain the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
    • Support clinical staff to implement the deviation process
    • Support Risk Management Plans for clinical activities
    • Support risk management and risk mitigation activities
    • Interact with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues
    • Ensure escalation to CQA Leader of major or critical quality issues or risks
    • Participate in regular CQA meetings to discuss QA/GCP issues and align/harmonize approach

    Additional/specific/projects responsibilities

    • Support organization of Global Clinical Meeting
    • Participate to and provide information and support for Annual Clinical Quality Review Meeting
    • Provide GCP guidance or quality advice to other DNDi functions (Fundraising, Procurement, Legal)

    Reporting line

    • S/he reports to the Clinical Quality Assurance Leader based in Geneva

    Job requirements

    Skills and attributes

    • Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
    • Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
    • Strong communication skills in multicultural, multi-lingual environments
    • Strong ability to work effectively as part of a multicultural team
    • Well organized and structured
    • Strong analytical skills
    • Strong ability to provide high level support in project/programme delivery
    • Strong ability to manage medium/large projects with budget management
    • Strategic thinking and leadership abilities
    • Strong management, negotiation, and advocacy skills
    • Have autonomy for taking actions and decisions
    • Strong ability to interact with external stakeholders
    • Lead and motivate a small team for optimum performance, supervising junior staff

    R&D technical skills

    • Good knowledge of drug discovery/development
    • Very strong knowledge of clinical research/development
    • Very strong knowledge of ethical principles, pertinent regulatory requirements and Good Clinical Practice (GCP), and company policies and procedures
    • Good knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)
    • Strong technical writing skills (procedures, protocols, and reports)

    Experience

    • Minimum 6 years’ relevant experience in which at least 4 years at Senior Officer level
    • Proven ability to work effectively in a team environment and matrix structure

    Education

    • Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level

    Other requirements

    • Fluency in English
    • Proficiency in local languages desirable
    • Very good knowledge of Microsoft Suite

    Other information

    • Status: Full time
    • Some travel will be required

    go to method of application »

    Senior Pharmacovigilance Manager

    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

    Method of Application

    Use the link(s) below to apply on company website.

     

    • Please submit your application using the online form
    • Deadline for application: Accepting applications until 28 August 2020
    • Only shortlisted candidates will be contacted
    • Application submission for this position may close early if we have enough suitable applicants

    Note: Never pay for any training, certificate, assessment, or testing to the recruiter.

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