Directly responsible for ensuring that adverse events are processed, analyzed and reported according to Corporate SOPs, local working instructions and local regulatory requirements
Drive the standardization of GDS information management (including implementation of self-service tools) to ensure consistency across solutions. Experience with Argus Safety, SQL programming/querying, custom report design/development preferably using a structured tool (e.g. Cognos, Business Objects).
FDA Commissioner Scott Gottlieb, once a critic of drug importation, is now tasked with the challenge of figuring out whether bringing certain low-cost drugs in from overseas will provide price relief for consumers.
July 18, 2018 – GDS Compliance Process and Standards – p b Job Responsibilities: /b /p ul li Review controlled process documents to ensure submitted procedures are compliant and meet the requirements
Global Drug Safety (GDS) Risk Management Lead is the drug safety expert for assigned products; maintains current knowledge of assigned product portfolio and safety profiles for products.
July 13, 2018 – Drug Safety Systems Analyst – p This position is an experienced analyst on the Global Drug Safety (GDS) Information Management team. /p p b Responsibilities: /b /p ul li
A pharmaceutical client has recently lost a Drug Safety Associate and looking for someone to back fill the role for 6-12 months. Ideal candidates would have QC and coding experience in drug safety capacity. This role will be assisting the client with case processing writing case narratives and queries.
Top Technical skills:
QC skills and experience
Argus coding experience
5 – 8 years of Drug Safety experience