Rio de Janeiro, Brazil
[Closing date: April 30, 2017]
Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org)
After 13 years of sustained growth, DNDi has built a team of approximately 200 full-time employees working across nine offices (Geneva, Rio de Janeiro, Kinshasa, Nairobi, New Delhi and Patna (India), Kuala Lumpur, New York and Tokyo).
The DNDi Latin America office was opened in 2004. With the primary aim to support regional R&D activities for Chagas disease and leishmaniasis, the Latin American office also undertakes advocacy and communications activities to increase neglected diseases awareness in the region. It also leads capacity building projects through multi-country research platforms.
DNDi Pharmacovigilance function’s aim is to provide clinical safety services to the entire DNDi organization in support of clinical trials conducted to develop treatments for Neglected diseases.
Terms of Reference
The Pharmacovigilance Manager provides support to the Global Pharmacovigilance function (based in Switzerland) in relation with DNDi-sponsored studies (conducted in Latin America, Africa, Asia, India and other regions) and contributes to the development of new treatments for Neglected Diseases. S/he oversees clinical safety activities on studies/programs assigned to her/him.
S/he is accountable for managing smaller scale projects and/or parts of the projects led by upper level, or delivering quality output through expert services or people.
Scope of Work (Results)
S/he role affects the performance of assigned projects and team and impact on larger programmes.
Tasks and Responsibilities (Job specific):
S/he will be responsible for the following clinical safety activities, primarily (but not exclusively) concerning clinical studies/activities assigned to her/him:
- 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) 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 program leadership.
- S/he reports to Senior Pharmacovigilance Manager based in Geneva, Switzerland.
- Works with clinical teams/program teams, and potentially all units in the R&D department involved in studies/programs assigned to her/him.
- Works with DNDi ’s global PV services provider, PV consultants and concerned Clinical Research Organizations.
Skills and Attributes:
- Good ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
- Ability to review many documents in a short time frame while maintaining consistency and solid attention to details.
- Clear and systematic thinking that demonstrates good judgment and problem solving competencies.
- Good communication skills in multicultural, multi-lingual environments.
- Strong ability to work effectively as part of a multicultural team.
- Well organized and structured.
- Good analytical skills.
- Good ability to provide high level support in project/program delivery.
R&D Technical Skills
- Excellent understanding of clinical safety regulations and processes.
- Good understanding of drug development, clinical process and Good Clinical Practices.
- Proven ability to work effectively in a team environment and matrix structure.
- Experience: minimum 6 years’ clinical development experience in which at least 4 years’ demonstrated experience working in clinical safety (within pharmaceutical companies, non-profit organizations or services providers).
- Medical degree.
- Fluency in English.
- Proficiency in Portuguese or Spanish.
- Very good knowledge of Microsoft Word, Excel, PowerPoint.
- MedDRA coding and WHO-DD coding knowledge.
- Eudravigilance user or XEVMPD certification would be a plus.
- Accepting applications until April 30, 2017.
- Only shortlisted candidates will be contacted.