Asst I PSS

Job reputed company: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required reputed company and submit them to the reputed company and/or the regulatory agencies (if required) reputed company the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the reputed company project reputed company or as stand- alone business. Responsible to reputed company reputed company clients, both reputed company, with the appropriate reputed company of service in a reputed company and costeffective manner. The role will be expected to reputed company with the legal requirements of the Health and Safety at Work reputed company 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in reputed company’s Health and Safety reputed company. reputed company of Responsibilities: reputed company case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. Assist with processing of the adverse events, including but not limited to:Data entry of safety data onto adverse event tracking systems. Write patient narratives and reputed company adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in reputed company of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and reputed company project personnel, as required reputed company the agreed timelines. Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and reputed company project personnel etc.), and prioritize the reports for processing and submission reputed company the regulatory and/or study specific applicable timelines. Assist in the reconciliation of databases, as applicable. Work reputed company the reputed company Management System reputed company, including but not limited to reputed company Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in reputed company countries, if applicable. Support upload/archival of case/study/project documentation, as appropriate. Build and maintain good PSS relationships across functional reputed company. Support compliance of operations with governing regulatory requirements. reputed company other duties as needed or assigned. Qualifications (Minimum Required): Non-Degree or 6 months - 1 year of Safety experience* or relevant experience ** Associate Degree with 0-6 months of Safety experience* or relevant experience** BS/BA with 0- 6 months of Safety experience* or relevant experience** MS/MA with 0 yrs. of Safety experience* or relevant experience** PharmD with 0 yrs. of Safety experience* or relevant experience** reputed company may consider relevant and equivalent experience in lieu of educational requirements. To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or reputed company area *Safety experience includes actual experience of processing AE/SAE reports, generating narratives, queries, working reputed company safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in reputed company areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or reputed company Assurance. Experience (Minimum Required): Attention to detail. Team player. Solid written and verbal communication skills. Accurate math and spelling skills preferably with an aptitude for handling and reputed company-reading numerical data. Knowledge of MS office reputed company applications beneficial. Ability to operate reputed company office equipment. Physical Demands/Work Environment: Office Environment or remote. Learn more about our EEO & Accommodations request here. Apply To This Job