- Company Name:
- Kelly Services, Inc.
Global Safety Scientist
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Global Safety Scientist for our client located in Thousand Oaks, CA.
Responsibilities (other duties may be assigned):
This role provides medical content and technical support to the GST in the evaluation of safety data and production of GST [Global Safety Team].
Provide medical and safety input into the clinical scope, review criteria, analysis and interpretation of safety data.
Develop and execute the safety surveillance strategy for product candidates/products in clinical development programs/approved products.
Support the GSO [Global safety Officer] in preparation of Risk Management Plans and other safety deliverables.
Manage the safety signal detection strategy for assigned products to author aggregate safety reports including PSURs.
Responsible for production of periodic reports and aggregate safety data analyses.
Responsible for evaluation of safety signals.
Support Global Safety Officer in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology.
May assist in producing presentations for Product Safety Review Meetings PSRM and other scientific presentations.
Contribute content support to the development of strategy and creation of, safety updates, safety assessment reports, and other GST deliverables.
MD required and 2+ years experience.
Understand post-marketing safety, 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.
Drug safety/drug development experience.
Adverse Event Management.
For immediate consideration, click the “Apply Now” button, or refer a friend by clicking the E-mail this job link provided.
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly services
. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com.
Kelly Services is an Equal Opportunity Employer.