Syneos Health Safety & PV Coordinator For Life Sciences
Syneos Health Safety & PV Coordinator For Life Sciences. BSc Life Sciences candidates with relevant experience to fill the vacancy of Safety & PV Coordinator at Syneos. Interested candidates apply for the vacancy given below:
Job Title: Safety & PV Coordinator
ID: 21002184
Primary Location Asia Pacific: Asia Pacific – IND-Hyderabad-Madhapur-Village
Job: Safety & Pharmaco
Schedule: Full-time
Travel: No
Employee Status: Regular
Description:
JOB SUMMARY:
In charge of aiding with departmental or project deliverables associated with the preparation and the handling of Individual Case Safety Reports (ICSRs) and also the preparation of expedited and also periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practices (GCP), regulatory standards, and also company and project-specific procedures.
JOB RESPONSIBILITIES:
- Monitors and routes incoming information to the appropriate project.
- Records all ICSR documentation and tracks based on Sponsor/customer specifications; distributes incoming mail and also faxes.
- Redacts patient identifying information/ images according to data protection standards, ICH GCP and also GVP.
- Enters data right into the safety database based on Sponsor/customer-specific guidelines and also Company requirements.
- Ensures current conventions are followed when entering cases right into the Safety database.
- Performs file creation, tracking, retention, and also maintenance (paper and also electronic).
- Manages the translation process for any type of source documents requiring translation.
- Performs or aid with query follow up process as instructed.
- Assists with submission processes as required.
- Assists with everyday workflow reconciliation.
- Maintains an understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH standards, Good
- Pharmacovigilance Practice (GVP) modules, study/program plans and also the drug development process.
Qualifications:
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 also capabilities to perform the job, with 1 years experience in clinical research.
- Safety Database systems and medical terminology favoured.
- Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or various other management/shared content/workspace) and internet.
Works with others as part of a team. - Capability to successfully focus on and also work with multiple tasks.
- Outstanding communication and also interpersonal skills, both written and spoken.
- Strong organizational and also documentation skills.
- Detailed oriented with a high degree of accuracy.
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