Safety Pharmacoepidemilogist FSP

Work Schedule

Environmental Conditions

Job Description

Make an Impact at the Forefront of Innovation! We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

The Safety Pharmacoepidemiologist will be primarily responsible for generating real-world data (RWD) to support our clients therapies with a focus on safety. They will identify evidence gaps in collaboration with other members of the SEI team 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 safety of our products while maintaining compliance with regulatory standards.

Responsibilities

• 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.
• He/she 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 in support of the clients innovative therapies.
• He/she will collaborate with SEI Leads and Scientists who monitor the safety of our products and relevant competitor safety profile(s) and who provide insights into differentiating aspects and evidence gaps.
• 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 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. An ambassador for appropriate use of RWD.
• Attend relevant internal and external meetings for training competitor intelligence and collaboration with KOLs and other plan and accomplish multiple work goals in a timely fashion.

Education and Experience Requirements:

• 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-years 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 indicationsis a plus
• Ability to travel up to 20% of time as needed

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills Abilities:

• 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 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. An ambassador for appropriate use of RWD.
• Attend relevant internal and external meetings for training competitor intelligence and collaboration with KOLs and other experts.

Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.