Top 3 Must Have Skill Sets:
Signal detection experience
Periodic report preparation
Document review such as clinical trial protocols, ICFs, Investigator brochures
Fully remote & can sit anywhere in the US
***Must have a degree AND 2+ years of relevant experience. Signal detection and report preparation is a must have.***
The Global Pharmacoviglance Scientist (GPvS) will join a team of PV Scientists working in collaboration with the Global Safety Officers (GSOs) to provide the safety strategy and major safety deliverables for product. The Immuno-oncology teams has an exciting portofolio of products ranging form Early Development through Marketed products.
The GPvS provides medical and safety input into the clinical scope, review criteria, analysis and interpretation of safety data. To develop and execute the safety surveillance strategy for product candidates/products in clinical development programs/approved products. To support the GSO [Global safety Officer] in preparation of safety deliverables.
Job Summary: This role provides medical content and technical support to the Global Safety Team (GST) in the evaluation of safety data and production of GST deliverables under the supervision of the GSO.
Key Activities: Support Global Safety Officer in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology. Responsible for producing presentations for team meetings and other scientific presentations under the guidance of the GSO. Contribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables. Safety content and expertise in support of IND filings, Investigator Meetings, Data Monitoring Committees and Data Review Teams, responses to regulatory authorities, safety sections of Clinical Study Reports, Clinical Summary of Safety, and other clinical trial documents
Competencies: Understand clinical trials and drug development. Clinical knowledge of therapeutic area patient populations and drug class. Understand safety data capture in CT and PM settings. Understanding of Medical Coding principles MedDRA. Knowledge of global safety requirements for worldwide pharmacovigilance. Critical Scientific thinking and problem solving. Attention to Detail. Teamwork and Interpersonal Skills. Microsoft Suite (Outlook, Word, Excel, PowerPoint). Organizational and Time Management Skills. Oral Presentation Skills. Written communications including medical writing. Basic Qualifications: MD, 2+ years experience. Drug safety/drug development experience. Adverse Event Management.
Master’s degree and 3 years of directly related experience
Bachelor’s degree and 5 years of directly related experience
"This posting is for Contingent Worker, not an FTE"