Clinical Epidemiologist

Région
Wavre
Publication
vendredi 19 mai 2017
Date limite
lundi 19 juin 2017
Réf
7491AXPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Clinical Epidemiologist Organisation description:

XPE Pharma & Science is looking for a Clinical Epidemiologist, a well-known company in pharmaceutical industry.

We need a MD or PharmD with Master's Degree (MS or MPH) or equivalent postgraduate qualification in Epidemiology, or Epidemiologist in infectious diseases and/ or vaccine-related epidemiology. At least 5 years of concrete experience are mandatory for this mission.

He/she contributes significantly to the development of a worldwide epidemiological strategy and research plan to accomplish the company strategic programs. Develops and disseminates information that helps advance company's understanding of the impact and burden of disease (including disease frequency, co-morbidity; outcomes; high risk groups; utilization of services; and disease natural history and trends.

Job description:

 Coordinates and implements epidemiological activities and critical studies for product development and access in line with the company's strategic programs:

 Finalizes medical plans and regulatory post approval plans for late development sand life cycle products. Finalizes global Epi plan for early products;

 Brings epidemiologic expertise and methodology to influence across phases of vaccine development in one or more vaccine/disease areas;

 Provides epidemiologic consultation at project & access/medical plan team level;

 Manages the internal presentation of the position on epidemiologic issues and effectively represents the comapny to external stakeholders, including regulatory authorities, international bodies, and key scientific opinion leaders;

 Responsible for the information provided in safety and regulatory documents regarding epidemiological data;

 Reviews in-house publications;

 Leads the design & conduct of epidemiological studies/projects in collaboration with clinical ops;

 Plans and coordinates scientific dissemination of epidemiological data, in consultation with internal & externsal stakeholders;

 Works effectively with the clinical development & access team to communicate about disease occurrence, disease understanding, payer evidence, risk management plan, and safety issues based on reviews of available literature and/or new studies;

 Contributes to the communications effort to support a company product or a relevant therapeutic area, including internal company presentations and papers, scientific presentations, and interactions with Advisory Boards, academic experts, and regulatory authorities;

 Participates in task forces/capabilities framework/working groups, development of policies/SOP/guidances related to epidemiological activities Assists with Internal adaptation of procedures & policies related to biomedical research with a focus on epidemiological research to guarantee compliance with international regulations. Partners externally with international initiatives (including Public Private Partnership)

Profile:

 Ideally at least 5 years of successful experience in project management of epidemiological studies at major pharmaceutical companies;

 Experience in a vaccine company is a plus;

 Excellent knowledge of the epidemiological research including post-authorization regulatory commitments (previous specific training is a plus);

Hard Skills:

 Formal training in infectious disease epidemiology/public health;

 Formal training in vaccinology and pharmaco-epidemiology are a plus such as having experience in conducting post authorization safety study and/or impact/effectiveness studies;

 Having experience in preparation and implementation of epidemiological projects in Africa is needed;

 Having experience in writing protocols, driving epidemiological studies, interpretation of complex data, and presentation at scientific congresses and writing scientific papers is needed;

 Training in the principles of epidemiologic study design, conduct, and quantitative analytical methods used for epidemiological studies;

 Strong skills in international health with the ability to effectively work on projects implemented in developing countries;

 Skills and ability to review the statistical and epidemiological literature to identify appropriate methodology to achieve research goals;

 Self-motivated with the ability to effectively work independently and in a team, and to develop credibility with colleagues within and outside Global Epidemiology;

 Ability to resolve problems through resourceful use of information and contacts;

 Able to understand and interpret scientific methods and information and communicate the data to both scientific and lay audiences, in written and presentation formats;

 Strong skills in using statistical tools and database software, as well as proficiency in collating and analyzing epidemiologic data;

 Excellent communication skills, both oral and written;

 Problem-solver; ability to see solutions to complex, unique situations where the epidemiological principles need to be applied;

 Ability to handle a high degree of change in priority projects. Ability to deal calmly with complex managerial and technical issues. Diplomacy and cross-cultural sensitivity;

 Ability to work well within a global and matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.

Soft skills :

 Customer oriented/ Service oriented; mature; calm under pressure;

 An organizer /planner /analyzer /implementer / problem-solver with demonstrated interpersonal skills;

 Team player.

Education, Methodology & Certification Requirements

 MD or PharmD with Master's Degree (MS or MPH) or equivalent postgraduate qualification in Epidemiology or Epidemiologist in infectious diseases and/ or vaccine-related epidemiology.

ICT Skills (software, operating systems, hardware, etc.)

 Microsoft Word

 PowerPoint

 Excel

Language Proficiency Requirements

English – Fluent

Offer:
  • Open end contract on XPE payroll;
  • Highly professional working environment.


Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713