Work as Safety & Pharmacovigilance Coordinator at Syneos Health

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Post : Safety & Pharmacovigilance Coordinator (1+ Year Experience in CT or Literature Data Entry)

Job Description
• Monitor and route incoming safety information to the appropriate project teams.
• Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes.
• Redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements.
• Perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards.
• Assist with case file creation, tracking, retention, and maintenance (paper and electronic).
• Support management of translation processes for source documents requiring translation.
• Assist with query follow-up activities as instructed.
• Support safety submission processes as instructed.
• Assist with daily workflow reconciliation activities.
• Maintain a working knowledge of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP modules, study/program plans, and the drug development process.

Candidate Profile
• Healthcare professional by education: B.Pharm / M.Pharm / PharmD / BDS.
• Minimum 1 year of experience in Pharmacovigilance in a full data entry / case processing role is mandatory.
• Experience in processing Literature and Clinical Trial (CT) cases is preferred.
• Experience with safety database systems and medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar document management systems), and internet applications.
• Strong ability to work collaboratively as part of a team.
• Ability to prioritize and manage multiple tasks effectively in a fast-paced environment.
• Excellent written and verbal communication and interpersonal skills.
• Strong organizational and documentation skills with high attention to detail and accuracy.
• Should be flexible to work in rotational shifts.

Additional Information
Experience : Minimum 1 year of experience
Qualification : B.Pharm / M.Pharm / PharmD / BDS
Location : Gurugram, Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Safety & Pharmacovigilance
End Date : 10th September 2026