Syneos Health is Hiring Safety & PV Coordinator

Syneos Health is Hiring Safety & PV Coordinator

15 July, 2022

Syneos Health is Hiring Safety & PV Coordinator

Job Responsibilities

  • Monitors and routes incoming information to the appropriate project
  • Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes.
  • Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP.
  • Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards.
  • Ensures current conventions are followed when entering cases into the Safety database.
  • Performs file creation, tracking, retention, and maintenance (paper and electronic).
  • Manages the translation process for any source documents requiring translation.
  • Performs or assist with query follow up process as instructed
  • Assists with submission processes as required
  • Assists with daily workflow reconciliation
  • Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.

Qualifications

What we’re looking for

  • B.pharms, M.Pharms, BDS 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, additional course in Pharmacovigilance 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

Apply HERE

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