R-Executive Epidemiology Researcher - Safety Outcomes, Evidera
R-Executive Epidemiology Researcher - Safety Outcomes, Evidera
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1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Team Overview
Evidera is a business within Pharmaceutical Product Development LLC (PPD) a leading global contract research organization (CRO). We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.
The Evidera Data Analytics team supportspharmaceuticalcompanies throughout the product lifecycle from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients build economic and epidemiological evidence to demonstrate and support the value of their products through analysis oflarge health administrative databases(e.g. medical claims electronic health records registries).
Position Summary
The Executive Epidemiology Researcher acts as the independent principal investigator (PI) of projects responsible for overseeing all aspects of delivery of retrospective studies using secondary data sources (e.g. EMR claims registries) to assess safety outcomes related to drug exposure. This may also include hybrid studies involving de novo data collection. Oversees and participates in a large project portfolio with a focus on pharmacoepidemiology treatment patterns and safety outcomes. This may include RWE research voluntary or mandated by regulatory agencies such as pregnancy and fetal outcomes studies PASS and PAES studies for the FDA EMA or other agencies. Acts as subject matter expert in strategic consultations and provides expertise on scientific methods. Innovates scientifically and produces output of high scientific quality. Assumes responsibilities for sales targets and client development.
Essential Duties and Responsibilities: (other duties may be assigned)
Independent PI of a large portfolio of projects responsible for overseeing all aspects of proposals and project delivery.
Responsible for project completion and quality delivery. Delegates coordination tasks to mid-level and junior staff.
Responsible for sales target with accompanying expectation around client/business development. Contributes to strategic thinking around sales and product development.
Identifies training needs for junior staff helps to develop relevant training materials provides recommendation on appropriate staff to lead trainings and serves as hands-on mentor.
Co-authors abstracts/articles for scientific publication in journals or presentation at scientific meetings.
Education Level/Years of Experience
Masters or PhD in Epidemiology or Public Health with a minimum of 10 years pharmaceutical experience including experience as a consultant with a pharmacoepidemiology or health economics and outcomes research (HEOR) focus.
Advanced understanding of epidemiology/pharmacoepidemiology within safety outcomes studies including PASS and PAES studies for the FDA EMA or other agencies. Understanding of statistics and experience in practical research implementation.
Proven experience in executing safety studies using large secondary data sources in the US UK and Europe such as medical claims electronic health records or registries
Proven record of relevant publications in peer reviewed journals and key scientific conferences
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.
Consulting Expectations
Client facing role within project delivery and providing senior level direction in the development and delivery of RWE proposals
Innovates scientifically and produces output of high scientific quality.
Extensive knowledge of drug development process evidence requirements and regulatory commitments in particular in the US (FDA) or Europe (EMA)
Managerial Duties
Line management responsibilities may be required
Personal Skills & Competencies
Analyzes complex issues and evidence identify cause-effect relationships and generate effective solutions.
Makes independent critical decisions based on relevant information. Applies solutions based on decisions in a timely manner.
Communicates and documents information effectively in written English including the ability to produce reports documents emails and other written pieces which are well-organized free from errors and are appropriately adjusted to the characteristics and needs of the audience.
Tailors and delivers high-level presentations to diverse audiences using a variety of communication delivery methods (e.g. written electronic oral interpersonal).
Leverages working relationships with customers and colleagues to quickly develop and sustain positive rapport build strong connections cooperation and collaboration in person over the phone and by email.
Desire and ability to guide and coach junior-to mid-to levels of scientific staff.
The role may require travel to scientific meetings/conferences and flexibility to work across time zones.
Perks
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.
Employment Type
Full-Time
