Pharmacovigilance Manager SA

Cape Town or Johannesburg, South Africa
[Closing date: 30 September
2018]                                                                 

 

The Drugs for Neglected Diseases initiative (DNDi), established in 2003 in Geneva, Switzerland, is a collaborative, patient-needs driven, non-profit drug research and development (R&D) organization that seeks to improve the quality of life and the health of people suffering from neglected diseases by using an alternative model to develop drugs for these diseases and by ensuring equitable access to new and field-relevant health tools.

DNDi is now working across 9 offices (Geneva, Rio, Kinshasa, Nairobi, New Delhi, Kuala-Lumpur, New York, Tokyo and most recently Cape Town) employing ~200 full time equivalent core staff and operating through a virtual business model with many partners, suppliers, and consultants. As part of its mission, DNDi advocates for increased public responsibility and a more enabling environment for neglected disease R&D at a global, regional, and national levels.

Since 2014, DNDi has initiated activities in South Africa, mainly with its currently ongoing Paediatric HIV programme and the extension of the ongoing HCV programme with clinical studies starting in South Africa in 2018.  A Memorandum of Understanding was signed in 2014 with the South African Department of Health for the Paediatric HIV programme. 

More recently, WHO and the DNDi have collaborated on the creation of the Global Antibiotic Research and Development Partnership (GARDP), to develop new antibiotic treatments addressing antimicrobial resistance. DNDi has agreed to facilitate the set up and hosting of the partnership and provide the scientific environment, necessary personnel and infrastructure to ensure an effective incubation period. GARDP as such is part of the DNDi institutional framework for the incubation period.

GARDP  signed a Memorandum of Understanding in 2016 with the South African Medical Research Council to establish the basis for close collaboration both institutionally and on specific projects including on drug development for neonates, sexually transmitted diseases, and drug discovery. GARDP launched two projects in 2017 and anticipate two additional projects in 2018, with drug discovery and substantial clinical activity in South Africa.

DNDi, in particular with the GARDP and the HIV/HCV programmes, aims to strengthen its presence in South Africa, and has established a Liaison office in Cape Town, hosted initially within the South African Medical Research Council, to support the R&D activities, manage the relationships with academia, pharmaceutical companies, and government agencies.

DNDi Pharmacovigilance function’s aim is to provide clinical safety services and drug safety/pharmacovigilance expertise to the entire DNDi organization in support of regulatory strategy and clinical trials conducted to develop treatments for neglected diseases.

 

Purpose of the position

The Pharmacovigilance Manager provides support to the global pharmacovigilance (PV) 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:

  • 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

 

Job requirements

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/programme delivery

R&D technical skills

  • Excellent understanding of clinical safety regulations and processes, including in Africa
  • Good understanding of drug development and clinical process, Good Clinical Practices and marketing authorization process, including in Africa
  • 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)
  • 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 or Pharmacist degree

Other requirements

  • Fluency in English
  • Proficiency in French 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 infectious diseases would be welcome

 

Reporting line

  • S/he reports to the Pharmacovigilance Leader based in Geneva, Switzerland
  • The Head of South Africa Liaison Office acts as the contributing manager

 

Interactions

  • Works with PV team, Clinical teams/Programme Heads or Leaders, and potentially all units in the R&D department involved in studies/programmes assigned to her/him.
  • Works with DNDi’s global PV services provider, PV consultants and concerned Clinical Research Organizations

 

Other information

  • Status: full time – permanent role
  • Possibility to work partially from home

 

To apply

  • Please submit your application using the online form
  • Deadline for application: Accepting applications until 30 September 2018
  • Only shortlisted candidates will be contacted