Safety & pv submission specialist II – home office

Responsabilidades

• Performs safety and pharmacovigilance program delivery activities including all aspects of the collection, processing, and reporting of individual cases safety reports, literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, data management activities and the preparation of expedited and periodic safety reports.
• Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• May assist in the preparation of the project plans such as Safety Management Plan.
• May perform set-up, delivery and close-out of safety and pharmacovigilance projects.
• Processes ICSRs according to SOPs and project-specific safety plans.
• 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.
• 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.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and 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.
• Quality review for the work performed by peers.
• Serves as a subject matter expert in SPVG, which includes resolution of project related routine queries; mentoring, coaching, and training of new hires.
• Fosters constructive and professional working relationships with all project team members, internal and external.
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
• Participate in audits/inspections as required.
• Ensures all relevant documents are submitted to the Trial Master File 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, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.

Requisitos

• Bachelor’s degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
• Safety Database systems and knowledge of medical terminology required.
• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
• Proficiency in Microsoft Office Suite, Visio, email, Team Share and internet.
• Ability to work independently and in a team environment.
• Excellent communication and interpersonal skills, both written and spoken.
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
• Detail oriented with a high degree of accuracy and ability to meet deadlines.
• Minimal travel may be required (up to 5%).

Marcado como: Análises Clínicas, Estudos Clínicos, Farmacologia, Farmacovigilância, Pesquisa Clínica