job title:safety and pv coordinator(syneos)

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.

Qualifications

What we’re looking for

• 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), TeamShare (or other 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