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
Minimum 3 years’ experience; preference for someone who has worked at multiple companies
Nursing or pharmacy background strongly preferred
Needs to have experience with the full case processing workflow (mailbox experience/assessing & triaging cases, data entry experience, quality check/review experience, follow up experience as well as submissions experience)
Argus database experience is an absolute must; experience with reports and listings in Argus, as well as experience coding AE and medication within Argus would be nice to have
Candidate would need to have a strong attention to detail, good communication skills, and ability to assess and think critically
January 5, 2018 – Drug Safety Specialist – p b Overview: /b /p ul li The Drug Safety Specialist may be responsible for supporting a number of clinical and postmarketing safety activities,