Job Overview:
Pharmacoepidemiology Consultancy activities, as support to the definition of RWE programs/initiatives and study design within the Clinical Development Plan Teams and Core Teams
Main Therapeutic Area: Respiratory (Asthma, COPD, chronic cough, IPF, PAH, neonatal Respiratory Distress Syndrom, Cystic Fibrosis)
Additional disease areas: Transplant, Critical Care
The consulting services entrusted to Service Provider consist of the following activities, designed to support with expertise the Real World Evidence Unit:
- Contribute to the project development strategy through RWE Strategy & Tactical Plan aimed to improve disease understanding relevant to drug development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs, and their variations across domains such as demographics and geographies
- Support and advises scientifically and from a methodological point of view on Real World Evidence strategies, as subject matter expert
- Contribute to integrated evidence generation strategies/plans for the project/product in scope.
- Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research plans/protocols and analysis of healthcare databases
- Collaborate with Scientific Societies on Disease Registries (Respiratory area as priority), to maximise the value extraction from their development and interrogation
- Identify innovative, timely and cost effective methods to conduct research activity dealing with Real World data and evidence, observational studies, epidemiologic studies, retrospective and prospective clinical registries, large electronic medical administrative registries, and health economics and outcome research (HEOR)
- Collaborate with RWE contractors and external vendors on RWE projects based on both primary and secondary data collection
- Develop and negotiate research plans with external collaborators in academia or contract research organizations and work effectively with vendors for outsourced studies
- Design definition and implementation for primary or secondary data collection or hybrid approaches for pharmacoepidemiologic studies, including protocol development and analysis specification following best methodological standards.
- Provide critical appraisal of observational studies and study protocols across the company.
- Drives the interpretation of analysis in collaboration with the multifunctional team and communicating analysis interpretation internally and externally.
- Contribute to publication and dissemination of pharmacoepidemiology studies.
- Performs Feasibility assessments and identification of fit-for-purpose data for RWE research
Education/Qualifications:
Master degree (ideally a PhD) in Epidemiology, Outcomes Research or other relevant scientific discipline
Experience:
- Proven experience in epidemiology, pharmacoepidemiology, observational studies (prospective studies, patient registries, retrospective database studies) real-world evidence (RWE) generation,
- Successfully delivered global and/or local RWE/pharmacoepidemiology projects from conceptualisation to publication within the pharmaceutical industry (or with a recognised expert consultancy or academic centre of excellence), using primary as well as secondary data, such as large healthcare databases, administrative registries, and health economics and outcome research (HEOR).
- Ability to discern strengths and limitations of real-world datasets — such as electronic health records, claims, clinical data registries, patient-generated health data, and other health data sources — in the context of designing epidemiology study designs
- Background knowledge of industry trends and best practices, specifically related to epidemiology/outcomes research.
- Good knowledge and understanding of applicable regulations in pharmacoepidemiology, pharmacovigilance and clinical development.
- Expertise in the EU5 and/or US healthcare environment
- Combination of strong methodological quantitative knowledge, strategic, innovative thinking, and communication skills.
- Proven ability to write/edit scientific communications (protocols, abstracts, poster presentations, podium presentations, manuscripts, etc.)
- Expertise in Respiratory Area preferred
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