Syneos Health Hiring Pharma Safety & PV Coordinator
Syneos announces job opening for pharma candidates for the post of Safety & PV Coordinator. Safety & PV Coordinator job opening at Syneos Health. Candidates with bachelor’s degree in Pharma can apply for the vacancy at Syneos Health for the post of Safety & PV Coordinator. Check out al the details on the same below:
Primary Location: Asia Pacific – IND-Hyderabad-Madhapur-Village
Job: Safety & Pharmaco
Schedule: Full-time
Travel: No
Employee Status: Regular
Job Title: Safety & PV Coordinator – (21002184)
Eligibility Criteria:
- Bachelor’s Degree in pharmacist, or an equivalent combination of education and experience that gives the individual the necessary
- knowledge, skills, and abilities to perform the job, with 1 year of experience in clinical research.
- 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
Job Summary
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.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.
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