Syneos Health is Hiring for a Safety &Pharmacovigilance Coordinator role | Apply Now
Explore the latest Pharmacovigilance jobs with top Pharma Jobs at Syneos Health for candidates with 1+ years of experience in Clinical Trial or Literature data entry. These full-time office-based Pharmacovigilance jobs in Gurugram and Hyderabad offer strong career growth in global drug safety, case processing, and safety data management with a leading biopharmaceutical organization.
- Job Title: Safety & Pharmacovigilance Coordinator
- Location: Hyderabad, Gurugram.
- Job ID: 25104873
About the Company
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Their Clinical Development model brings the customer and the patient to the center of everything that they do. The Company is continuously looking for ways to simplify and streamline work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to helpcustomers achieve their goals.
Job Description
This Pharmacovigilance job role supports Pharma Jobs operations through safety case processing, data entry, documentation handling, safety database management, and compliance with global safety regulations and sponsor requirements.
Key Responsibilities
- 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 the 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.
Qualifications
- 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 close attention to detail and accuracy.
- Should be flexible to work in rotational shifts.
