[Closing date: 30 January 2016]
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development organization working to deliver new treatments for neglected diseases, in particular sleeping sickness (human African trypanosomiasis), Chagas disease, Leishmaniasis, specific helminth infections, malaria, Mycetoma, HCV and paediatric HIV.
Contributing to the development of new treatments for Neglected Diseases, The Pharmacovigilance Senior Manager will support all pharmacovigilance activities in relation with Clinical studies .
As a member of the DNDi R&D team, s/he will report to the Medical Director.
Specific Job Responsibilities:
The PV Senior Manager will be responsible for :
- Defining, establishing and maintaining DNDi’s Pharmacovigilance System for clinical trials in compliance with PV and GxP regulatory requirements and DNDi’s Quality System (working closely with QA manager), with the support of PV service providers/Clinical Research Organisations (CROs) and DNDi local/central clinical teams, as necessary; This includes the preparation and maintenance of standard operating procedures, working instructions and templates.
- Ensuring that all PV-related activities related to the management of DNDi-sponsored clinical studies are performed by trained personnel (DNDi or external personnel) and compliant with applicable local/international safety reporting requirements,
- Supervision of PV-services providers/PV associates, coordination of Clinical Research Organisations (CROs) or DNDi regional clinical offices (in charge of clinical study sites monitoring, local regulatory activities and clinical data management) and central clinical program leadership teams with regards to PV,
- Preparation or review of study-specific study management plans (SMP; defining roles and responsibilities of each party involved in clinical safety data flow and management; processes, templates and timelines),
- Quality control and medical safety review (including causality, expectedness and reportability assessment) of Individual Case Safety Reports (ICSRs), together or with contribution (as necessary) of the Medical Director, Medical Manager/Program Directors or other appropriate clinical team members, as defined for each study,
- Contribution to safety signal detection activities, clinical study output analysis and risk management plan preparation, together with the Medical Director and clinical team members, as defined for each program/study,
- Preparation or review, and approval of safety cases line listing (LL) and aggregated safety reports (i.e. DSUR); contribution to study-specific annual progress reports prepared by clinical teams (Incl. by LL preparation),
- Prepare or review, with contribution from the Medical Director and Program heads/clinical teams, Safety Data Exchange Agreements (SDEAs) with pharmaceutical partners,
- Contribution to Investigator’s Brochure preparation with regards to safety data and preparation of development safety reference information (summary of data and guidance provided to the investigators; basis for expectedness assessment),
- Definition of cut-off dates for all periodic safety reports (PLL or DSUR),
- Approving CIOMS I submission and Dear Investigator Letters, together with the Medical Director/Program heads, as appropriate.
Qualifications / Person specification
- Review many documents in a short time frame while maintaining consistency and attention to detail
- Ability to prioritize work accordingly to meet departmental needs and independently work toward and meet deadlines
- Work with clinical study documents, either generated internally by DNDi or received from CROs/partners, including meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate
- Understanding of the drug development and clinical process
- Minimum of 10 years’ experience in Clinical Operations and pharmacovigilance
- Master’s degree in a relevant field.
- Fluent in English and good knowledge of other languages (French, Spanish or Portuguese)
- Ability to work in a multicultural environment
- Experience / expertise in training and managing PV staff
Must be expert at using Microsoft Word, Excel, and SharePoint.
Ability to multi-task,
Excellent communication skills and attention to detail are all key for this role.
Please send via email the following two documents: (1) a letter explaining why you are applying for this post, and (2) your CV/resume to DNDi: firstname.lastname@example.org.
Please indicate in the subject line of your email: Head of PV
Accepting applications until January 30th, 2016