Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a focus on clinical development, medical affairs, and commercial insights, Syneos Health delivers innovative solutions to meet modern market demands.
Operating in 110 countries with 29,000 employees, Syneos Health is committed to simplifying processes and improving patient outcomes. The company fosters a Total Self culture, promoting diversity, inclusion, and professional growth.
Job Description
Syneos Health is hiring a Safety & Pharmacovigilance (PV) Coordinator for its Hyderabad (Raheja Mindspace) office. This role is ideal for professionals with 1-2 years of experience in ICSR (Individual Case Safety Report) case processing.
Key Responsibilities:
- Monitor and route incoming safety data to appropriate project teams.
- Record and track ICSR documentation as per sponsor/customer requirements.
- Redact patient-identifying information in compliance with ICH GCP, GVP, and data protection laws.
- Enter case data into safety databases following company and sponsor guidelines.
- Manage file creation, tracking, and maintenance (electronic & paper-based).
- Coordinate translation of source documents when required.
- Assist in query follow-ups and submission processes.
- Ensure compliance with SOPs, Work Instructions, and global pharmacovigilance regulations.
Qualifications & Skills:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- 1-2 years of experience in ICSR case processing.
- Familiarity with safety databases, medical terminology, and pharmacovigilance regulations (GVP, ICH GCP).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and safety databases.
- Strong organizational skills with the ability to multitask and meet deadlines.
- Excellent written and verbal communication skills.
- Ability to work independently and in a team environment.
Why Join Syneos Health?
- Career Growth: Opportunities for professional development and progression.
- Training & Support: Access to technical and therapeutic training programs.
- Inclusive Culture: A Total Self workplace that values diversity and authenticity.
- Global Impact: Work on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products.
How to Apply?
