Safety and Pharmacovigilance Specialist II

hace 4 semanas

Xico, México Syneos - Clinical And Corporate - Prod A tiempo completo
About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

Job Responsibilities
  • Enter information into PVG quality and tracking systems for receipt and tracking of ICSR as required.
  • Assist in the preparation of project plans, such as Safety Management Plans.
  • Perform set-up, delivery, and close-out of safety and pharmacovigilance projects.
  • Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
  • Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability.
  • Enter data into safety databases.
  • Code events, medical history, concomitant medications, and tests.
  • Compile complete narrative summaries.
  • Assess information to be queried and follow up until information is obtained and queries are satisfactorily resolved.
  • Participate in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
  • Coordinate with data management staff concerning reconciliation of safety data between the clinical and safety databases.
  • Maintain safety tracking for assigned activities.
  • Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.
  • Validate and submit 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.
  • Foster constructive and professional working relationships with all project team members, internal and external.
  • Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
  • Ensure 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.
  • Ensure 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.
  • Maintain 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.
Qualifications

We are seeking a highly skilled and experienced Safety and Pharmacovigilance Specialist II to join our team. The ideal candidate will have a Bachelor's Degree in a 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.

The candidate should have a 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. Excellent communication and interpersonal skills, both written and spoken, are essential for this role. The candidate should also have good organizational skills with proven ability to prioritize and work on multiple tasks and projects.

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