Safety & PV Coordinator I Fresher's job

JOB SUMMARY
Responsible for assisting with departmental or project deliverables, and with the preparation and the processing of Individual Case Safety Reports (ICSRs), while adhering to all data privacy guidelines, Good Clinical Practices (GCP), regulatory guidelines, and company and project-specific procedures

JOB RESPONSIBILITIES
 Monitor and route 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 and ICH GCPs and GVP.
 Enters data into the safety database in accordance with customer specific guidelines and Company standards.
 Assists with file creation, tracking, retention, and maintenance (paper and electronic).
 Assist with the management of the translation process for any source documents requiring translation.
 Assists with query follow up process as instructed
 Assist with submission processes as instructed
 Assist 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.

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), 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

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