Syneos Health is Hiring Safety & PV Coordinator
- 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.
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