Job Title:
Safety & Pharmacovigilance (PV) Coordinator
Location:
Gurugram, Haryana, India
Company:
Syneos Health®
Job ID:
25101792
Job Category:
Safety / Pharmacovigilance
Position Overview:
The Safety & PV Coordinator supports pharmacovigilance activities by monitoring, recording, and processing adverse event information in compliance with regulatory guidelines and sponsor requirements. This role ensures accurate data entry, case tracking, and quality control to maintain the integrity of safety data across clinical trials and post-marketing programs.
Primary Responsibilities:
Monitor and route incoming safety information to appropriate projects.
Record and track Individual Case Safety Reports (ICSRs) in accordance with sponsor/customer specifications.
Redact patient identifying information/images in compliance with data protection, ICH GCP, and GVP guidelines.
Enter data into safety databases following company and client standards.
Perform or assist with query follow-up processes.
Assist with submission processes, daily workflow reconciliation, and literature screening.
Assist in coding events, medical history, concomitant medications, tests, and narrative writing.
Validate xEVMPD product records and recode un-recoded product/substance terms.
Identify and manage duplicate ICSRs.
Support activities related to SPOR/IDMP as required.
Ensure relevant documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF).
Maintain understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH, and GVP guidelines.
Foster constructive and professional working relationships with project teams, internal and external stakeholders.
Participate in audits and apply regulatory intelligence to safety reporting activities.
Qualifications & Skills:
Bachelor’s Degree in Life Sciences, Pharmacy, Nursing, or equivalent combination of education and experience.
Familiarity with safety database systems and medical terminology preferred.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare, and internet.
Strong organizational, documentation, and multitasking skills.
Excellent communication and interpersonal skills (written and spoken).
Detail-oriented with a high degree of accuracy.
Ability to work effectively both independently and as part of a team.
Work Environment & Additional Information:
Office-based in Gurugram with hybrid flexibility as required.
Tasks and responsibilities may evolve based on project and business needs.
Syneos Health promotes career development, peer recognition, and a diverse and inclusive work environment.
Commitment to compliance with local and global employment laws, including reasonable accommodations for disabilities.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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