Pharmacovigilance Consultant – Fixed term – 1 year

New Delhi, India
[Closing date: 14 October
2019]

 

Established in 2003 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.

After 15 years of sustained growth, DNDi has built a team of approximately 240 employees working across nine offices (Geneva, Rio de Janeiro, Kinshasa, Nairobi, New Delhi, Kuala Lumpur, New York, Tokyo, and Cape Town).

Opened in 2004, the DNDi India office supports the implementation of R&D projects on visceral leishmaniasis, along with activities in hepatitis C, filariasis, paediatric HIV and AMR. The office also works closely on raising awareness and advocating for increased public responsibility and a more enabling environment for neglected disease and neglected patient R&D. 

 

Purpose of the position

The Pharmacovigilance Consultant will provide support to the global Pharmacovigilance function (based in Switzerland) in relation with clinical trials (conducted in Asia, India, and other regions) contributing to the development of new treatments for neglected diseases.

 

Specific job responsibilities

S/he will provide the following clinical safety services, primarily (but not exclusively) concerning clinical studies/activities assigned to her/him:

  • Contribution to study -specific PV training materials and safety-related sections of study documents (synopsis, protocol, clinical study report, medical monitoring plan) together with other PV team members and in collaboration with clinical team members, 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 signal detection, safety risk management activities, clinical development plan, investigator’s brochure as per standard operating procedures and as defined for each project assigned,
  • 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 clinical trials 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 Organisations (CROs), DNDi regional offices and central clinical programme leadership.

 

Reporting line

  • Reports to the Head of Pharmacovigilance based in Geneva (headquarter)
  • Second reporting line to the Head of the New Delhi office

 

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

R&D technical skills

  • MedDRA and WHO Drug Dictionary coding knowledge
  • Understanding of the drug development and clinical process

Experience

  • Demonstrated experience of 6 years within pharmaceutical companies, non-profit organisations, or services providers including (3-5 years) in clinical safety
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in private sector is highly desirable

Education

  • Medical Doctor degree

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Very good knowledge of Microsoft Suite

 

Other information

  • Status: Full time – Consultancy – 1-year contract
  • Expecting starting date: December 2019

 

To apply

  • Deadline for application: Accepting applications until 14 October 2019
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants