Syneos Health™ is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Acceleration Model delivers value across the small to mid-size to large customer continuum.
Post : Safety & PV Coordinator
Responsible for assisting with departmental or project deliverables associated with the preparation and the processing of Individual Case Safety Reports (ICSRs) 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.
• 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.
• Freshers – 2020 Pass out only.
• 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
Qualification : Bachelor’s Degree in life science, registered nurse, pharmacist
Location : Gurgaon-Cyber-City
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Safety & PV
End Date : 30th December, 2020
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