Full Time
Florida
Posted 1 year ago

Senior Epidemiologist or Associate Director, Safety Epidemiology

The Senior Epidemiologist or Associate Director works independently in the design, execution, analysis, interpretation, and internal and external communication of specific epidemiological studies and literature reviews. This role requires taking a leadership role in a range of activities, including delivery of experienced epidemiology strategy, support, and scientific leadership to project teams and the epidemiology global skills group, at all stages of pharmaceutical development. They will manage externally commissioned research projects, which includes establishing, maintaining, and expanding relationships to partner effectively with external experts and research groups to negotiate time frames, provide recommendations on resource requirements, and ensure delivery of the tasks as agreed. They will promote good epidemiological practice and represents the company’s position when interacting with external experts, collaborative groups, and contract research organizations; and will keep abreast of epidemiological developments within academia, regulatory, and among key opinion leaders. Essential

Requirements

Ph.D. or equivalent in pharmacoepidemiology, epidemiology or related health science field and substantial experience in the health care environment. Alternatively, an MSc or MPH with consolidated experience in the health care environment.
Hands-on experience in utilizing secondary data and primary data collection studies and knowledge of patient safety databases for use in generating RWE.
Ability to apply advanced epidemiological theory and techniques
Able to provide critical appraisal to study designs and published studies
Ability to work effectively with internal & external experts, collaborative groups and contract research organizations (CROs)

Preferred

A broad global pharmacovigilance knowledge including knowledge of PASS studies, post-marketing commitments and reporting requirements
Understanding of drug safety and medical terminology and ability to summarize medical information drug safety experience in a clinical or post-marketing environment.
Ability to effectively represent epidemiology and pharmacovigilance operations on multidisciplinary teams
Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management
Knowledge and experience with drug safety reporting and regulatory compliance and experience with international drug safety reporting/regulations, including PASS and RWE studies, Risk Management Plans and Signal Management
Previous experience in managing communication with EMA and FDA
Substantial knowledge and experience in epidemiological methods and research in drug development or in a closely related academic research area
Knowledge of clinical trial activities and reporting requirements

To apply for this job please visit orbiterrecruiting.com.