PharmD Info

Job Title: PV Coordinator

Company: Syneos Health Clinical Solutions

Qualification: B Pharm/ Pharmacy

Location: Asia Pacific - IND-Gurgaon-Cyber-City

Job Responsibilities: 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.

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