Safety Scientist (m/f/d)

REFERENCE NUMBER:

402284/11

MY DUTIES:

-Represent Safety Science with business process owners on processes executed by Safety Science
-Responsible for coordination and collaboration with vendors servicing Safety Science
-Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER
-Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports
-Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
-Contribute to study management through SMT/PET and document review across the development continuum (early phase to post marketing studies), including PASS
-Interface with business process owners on processes executed by Safety Science
-Coordinate and assist in responding to Health Authority requests
-Responsible for supporting processes involving safety science such as the expected terms list, MedDRA baskets, ICF process, etc.
-Support product quality issues
-Responsible for carrying out activities related to quality system management for safety science

MY QUALIFICATIONS:

-Bachelor’s degree in healthcare related field or equivalent experience
-Experience in Oncology
-Work experience in pharma safety, pharmacovigilance or other related pharmaceutical
-Development area preferred
-Appreciation of GxP (GVP) and regulated processes and end to end clinical trial lifecycle
-Strong orientation towards cross-functional teamwork
-Able to work with remote partners and teams across global sites
-Autonomous and attention to details
-Excellent communication skills, both written and verbal
-Understanding on application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
-Fluent in English

MY BENEFITS:

-You will work in an international environment

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Athina Hondroulidou

Reference number
402284/11

Contact
E-Mail: [email protected]