Thermo Fisher Scientific
Pharmacoepidemiologist (Safety) - client dedicated
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Work Schedule
Standard (Mon-Fri)
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This role will be working within our Functional Service Partnership (FSP) team, fully embedded into our client partner where you will be working remotely in Europe. The position may require approx 20% travel to Belgium and the USA.
The Pharmacoepidemiologist will be primarily responsible for generating real-world data (RWD) with a focus on safety. They will identify evidence gaps, develop methodology, and oversee the conduct of real-world studies. This role involves collaboration across functional areas, fostering continuous improvement, and engaging with external stakeholders, including vendors and key opinion leaders (KOLs).
This role combines medical/scientific expertise, data analytics, and strategic thinking to ensure the product safety while maintaining compliance with regulatory standards.
The main purpose is to design and execute Pharmaco-Epidemiology activities and studies addressing safety research questions in the context of drug development, regulatory submissions, and marketed products. This will include data mining and analyses using various external sources such as claims data, electronic health records, registries, PAS, or others.
You will collaborate with internal and external stakeholders and other decision makers to lead the planning, design, and any other contribution(s) to real-world studies.
You will collaborate with internal teams who monitor the safety of products and relevant competitor safety profile(s), and who provide insights into differentiating aspects, and evidence gaps.
Role Responsibilities:
- Design and execute Epidemiology studies addressing safety research questions.
- Identify epidemiological / pharmaco-epidemiological methods, relevant data sources, best suited to address safety research questions. This includes but is not limited to conducting the feasibility, designing, preparing study concepts, protocols, and statistical analysis plans, and report of pharmacoepidemiologic studies.
- Transfer epidemiologic expertise and deliverables to the evaluation, refinement and contextualization of safety findings. Utilize analytical methods to interpret real world data, support the identification of safety data gaps in order to generate relevant insights.
- In collaboration with key functional areas (RWE, Medical Affairs, GPS, Regulatory, HEOR, Clinical Development, Clinical Science), contribute to the development of Integrated Evidence Generation Plans (IEGPs), including the planning, prioritization, and execution of real-world studies, with particular focus on safety aspects and outcomes.
- Communicate safety RWD internally and externally promptly with all relevant stakeholders. Collaborate with Scientific Communications on integrated publication plans for safety evidence.
- Foster a continuous learning/improvement with all internal/external stakeholders.
- Attend relevant internal and external meetings for training, competitor intelligence, and collaboration with KOLs and other experts.
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Education, Qualifications + Competencies:
- Background in health and life sciences (epidemiology, public health, MD, pharm D), or quantitative data sciences, biostatistics
- PhD in Epidemiology and/or pharmacoepidemiology or equivalent advantageous
- At least 5-year experience in epidemiology/ pharmacoepidemiology as well as in drug safety
- Excellent written and oral communication skills in English
- Strong medical/scientific background, inspired by prioritizing patient safety.
- Good working knowledge of both GCP and GVP.
- Substantial prior experience of working with RWE/D within the pharmaceutical industry, particularly in the application of RWE in drug development for rare indications is a plus
- Ability to travel up to 20% of time as needed
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Required Skills/Experience:
- Proven experience including a track record in executing pharmacoepidemiology studies using RWD.
- Highly developed analytical skills to understand complex matrix linkages of safety data from various sources.
- Collaborative with strong communication, interpersonal, and leadership skills and a proven track record of working and communication successfully within a complex multi-disciplinary environment.
- Strong active listening skills with ability to incorporate input from a variety of internal and external stakeholders.
- Drives initiative with ability to work with minimal supervision.
- Good organizational skills and “hands on” attitude, reliable and solution oriented.
- Effective in setting clear priorities among competing activities. Leverages experience and know-how to focus on priority objectives.
- Embraces innovation by constantly seeking new ways to get results in different situations.
- Proactively evaluates and participates in ongoing professional development opportunities in order to leverage the best in class approaches to real world data evidence generation.
Why join us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
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