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Drug Safety Associate

JOB207 | Full Time

Location: Jersey City | United States

Salary: 70000 /

Employer: The Veritas Healthcare Solutions, LLC

BENEFITS •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. Job Requirements: • 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