DRUG SAFETY SPECIALIST COMMACK, NY Assist with the receipt, assessment, tracking, follow-up, and regulatory reporting of adverse drug experiences received by Pharmacovigilance Safety Database. Triage events for expectedness and reportability along with the Contract Research Organization (CRO); Review adverse drug experience reports entered into the Safety Database; Review the narratives, follow-up requests, and coding adverse events in MedDRA in conjunction with medical monitors and prepare line-listings and narratives as requested for safety reviews; Prepare and maintain internal filing systems; archive safety files and scan source information for archival in electronic systems. Collaborate with internal departments to support and develop standard operating procedures/working practices/collection forms and adhere to company and departmental SOPs as required. Assist with submission of expedited reports to Health Authorities globally. Ensure compliance with internal procedures, regulatory requirements and contractual requirements of Safety Data Exchange Agreements (SDEA) with business partners. Manage expedited submission history in safety database and tracks reporting compliance with regulations; Contribute to the timely preparation of ad-hoc and aggregate reports, including Developmental Safety Update Reports (DSURs), 6-monthly SUSAR Line-Listing Reports, IND annual reports, liaising with managers, physicians, and Pharmacovigilance colleagues as appropriate; Salary: $73,008/YEAR REQUIREMENTS ARE: Master’s degree in Pharmacy or a related field of study. 1 years’ experience in drug safety/Pharmacovigilance role. Mail resumes to: Akron Generics LLC, Akron Generics 47 Mall Drive, UNIT 1 & 2 Commack NY 11725

　　Minimum Salary: 73008.00Maximum Salary: 73008.00Salary Unit: Yearly