Job Vacanciesa at Drugs for Neglected Diseases initiative (DNDi)

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 »

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