•All relocation expenses will be covered (travel & accommodation).
•401K Savings Plan
•E-Verified Employer- H1-B Sponsorship for qualifying candidates.
•Comprehensive Health Insurance.
The Drug Safety Associate will perform activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds.
• Ensure accurate transfer of information from initial and follow-up source documents for adverse event reports to appropriate fields within ARGUS; code adverse events using MedDRA, create narrative of the adverse events, and manage case reports within the ARGUS workflow to meet local and global regulatory timelines.
• Process case-related information including interpretation of medical conditions, lab results, and procedures; ensuring proper coding of data into the global safety database.
• When required, perform timely and accurate triage of adverse event reports, complaints, & inquiries from physicians, pharmacies, consumers and sales reps.
• Correspond with health care professionals, consumers, and company personnel regarding safety issues with marketed products.
• Correspond and interface with CRO’s regarding collection of safety information for development products.
• Assist with SAE reconciliation activities with internal departments and external partners as needed.
• Ensure timely preparation & submission of reports to regulatory agencies in accordance with applicable regulations - including US PADER, IND Annual reports and ASR reports.
• Participate in clinical team meetings supporting the Shionogi development portfolio as representative of Drug Safety, when needed.
• Review literature citations weekly for appropriate reporting and collection of safety information for both marketed and development products.
• Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management.
• Bachelor degree in Pharmacy or Nursing.
• Previous experience with safety database programs; i.e., Argus, Aris-G, etc. desired
• Previous experience using medical terminology and MedDRA coding desired.
• Understanding of regulations relevant to the safety of drugs in development and post authorization as well as knowledge of clinical research.
• Applied knowledge of global regulations and global compliance timeline desired.
• Ability to work in a team environment.
• Written and verbal communication