Pharmacovigilance Manager South-East Asia

Kuala Lumpur, Malaysia
[Closing date: 25 November 2018]
                                                     

 

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.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research & Development Partnership, a not-for-profit research and development organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.

Since its inception, DNDi has developed seven new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, and paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

DNDi was established in Malaysia in 2004 based in Penang, working closely with the University Sains-Malaysia. With the shift in focus of regional activities to hepatitis C, the DNDi office was moved to Kuala Lumpur.

The DNDi Pharmacovigilance function’s aim is to provide clinical safety services as well as drug safety and 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 function (based in Switzerland) in relation with DNDi-sponsored studies (conducted in Asia, Latin America, Africa, India, and other regions) and contributes to the development 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
  • Contribution to marketing authorization registration dossier from a drug safety perspective
  • 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
  • Support 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 Asia
  • Good understanding of drug development and clinical process, Good Clinical Practices
  • Good understanding of marketing authorization process, including in Asia
  • 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
  • Experience in HCV, HIV, and/or infectious diseases would be welcome

Education

  • Medical or Pharmacist degree

Other requirements

  • Fluency in English
  • Proficiency in Bahasa or Thai is 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

 

Reporting line

  • S/he reports to the Pharmacovigilance Leader based in Geneva, Switzerland
  • The Head of DNDi South-East Asia acts as 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 – 2 years fixed term contract renewable

 

To apply

  • Deadline for application: Accepting applications until 25 November 2018
  • Only shortlisted candidates will be contacted