JOB SUMMARY

Responsible for assisting with departmental or project deliverables associated with the preparation and the processing of Individual Case Safety Reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which include cleansing and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ICSR reports, management of duplicate ICSR cases, quality review of ICSRs, Substances, Products, Organizations and Referential (SPOR), Identification of Medicinal Products (IDMP) activities) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practices (GCP), regulatory guidelines, and company and project-specific procedures. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.
JOB RESPONSIBILITIES
• Monitors and routes incoming information to the appropriate project if required.
• Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes if required.
• Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP if required.
• Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards if required.
• Ensures current conventions are followed when entering cases into the Safety database.
• May perform file creation, tracking, retention, and maintenance (paper and electronic).
• Manages the translation process for any source documents requiring translation if required.
• Performs or assist with query follow up process as instructed.
• Assists with submission processes as required.
• Assists with daily workflow reconciliation.
• Assists with literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, if required.
• Assists with narrative writing.
• Assists with coding events, medical history, concomitant medications, and tests.
• Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Validation of xEVMPD product records, including appropriate coding of indication terms using MedDRA, if required.
• Manual recoding of un-recoded product and substance terms arising from ICSRs if required.
• Identification and management of duplicate ICSRs if required.
• Activities related to SPOR / IDMP if 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 of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/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.
QUALIFICATION REQUIREMENTS
• 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 medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
• Works with others as part of a team
• Ability to successfully prioritize and work on multiple tasks.
• Excellent communication and interpersonal skills, both written and spoken
• Strong organizational and documentation skills
• Detailed oriented with a high degree of accuracy