Safety Specialist

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required
• Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
• Enters data into safety database
• Codes events, medical history, concomitant medications, and tests
• Compiles complete narrative summaries
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved
• Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Maintains safety tracking for assigned activities
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA
• Manual recoding of un-recoded product and substance terms arises from ICSRs
• Identification and management of duplicate ICSRs
• Activities related to SPOR / IDMP
• Quality review of ICSRs
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process
• Fosters constructive and professional working relationships with all project team members, internal and external
• Participates in audits as required/appropriate
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities

Safety & PV Specialist ensuring accurate processing and tracking of safety data

Safety & PV Specialist I, Russian Fluent

Safety & PV Specialist responsible for processing ICSRs and maintaining safety tracking systems at Syneos Health. Collaborating with teams to ensure compliance and quality in pharmacovigilance activities.

• Perform all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.
• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program specific safety plans
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
• Enters data into Argus Safety Database
• Code events, medical history, concomitant medications and tests
• Draft case narratives
• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
• Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
• Participates in audits/inspections as required
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings
• Participates in project specific teleconferences/meetings as required
• Other duties assigned by management

Safety Specialist II in clinical trials at Precision for Medicine

Safety Specialist II

Safety Specialist II at Precision for Medicine supporting clinical trial safety processes. Handling individual case safety reports and regulatory compliance in clinical environments.

• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
• Enters data into Argus Safety Database
• Code events, medical history, concomitant medications and tests
• Draft case narratives
• Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
• Participates in audits/inspections as required
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process

Safety Specialist II managing safety reports for clinical trials at Precision Medicine Group

Safety Specialist II managing safety reports for clinical trials. Integral part of the safety team at Precision Medicine Group, handling data for clinical trials and safety programs.

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Safety & PV Specialist I, Russian Fluent

Safety Specialist II

Safety Specialist II