Safety Pharmacoepidemilogist - FSP

Thermo Fisher Scientific

2d•Onsite

About The Position

Make an Impact at the Forefront of Innovation! We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 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 client's 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.

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.

Nice To Haves

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

Responsibilities

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 client's 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 experts.
Evaluate, plan and accomplish multiple work goals in a timely fashion.