Life Science Vacancy at Syneos Health
Searching for a rewarding Life Science Vacancy in the pharmacovigilance and drug safety industry? Here’s an exciting opportunity from Syneos Health Careers for candidates passionate about patient safety, clinical research, and regulatory compliance. This opening for Safety & PV Specialist I is ideal for professionals looking for BSc Life Science Jobs with global exposure in pharmacovigilance operations and clinical trial safety management. If you are searching for an excellent opportunity for life science graduates, this role could be your perfect gateway into the healthcare and pharmaceutical industry.
About the Company
Syneos Health is a leading integrated life sciences organization focused on accelerating customer success across the drug development and commercialization continuum. The organization partners with innovators globally to support clinical development, regulatory compliance, and patient-centered healthcare solutions. The company promotes an inclusive work environment with strong emphasis on employee development, technical training, and collaborative innovation.
Job Details:
- Job Title: Safety & PV Specialist I
- Company: Syneos Health
- Job Type: Full-Time
- Work Mode: Office-Based
- Locations: Pune, Gurugram, Hyderabad
- Job Requisition ID: 25107802
Role Overview
The Safety & PV Specialist I will support pharmacovigilance and drug safety operations by processing Individual Case Safety Reports (ICSRs), ensuring regulatory compliance, maintaining safety databases, and contributing to post-marketing and clinical trial safety activities.
The role requires expertise in pharmacovigilance workflows, case processing, safety reporting regulations, and medical coding standards.
Key Responsibilities
- ICSR Processing & Safety Reporting
- Process Individual Case Safety Reports (ICSRs) according to SOPs and project-specific safety plans
- Triage and evaluate safety cases for completeness, accuracy, and regulatory reportability
- Enter and maintain data within pharmacovigilance safety databases
- Compile narrative summaries and follow up on missing or incomplete information
- Support timely generation of expedited safety reports as per regulatory requirements
- Coding & Database Management
- Perform MedDRA coding for adverse events, medical history, and concomitant medications
- Conduct drug coding and maintain drug dictionaries
- Validate and submit xEVMPD product records with appropriate coding
- Manage manual recoding of unresolved product and substance terms
- Identify and manage duplicate ICSRs
- Pharmacovigilance Compliance
- Support activities related to SPOR / IDMP
- Conduct quality review of ICSRs
- Ensure compliance with SOPs, GCP, GVP, ICH guidelines, and global pharmacovigilance regulations
- Maintain Trial Master File (TMF) and Pharmacovigilance System Master File documentation
- Literature & Regulatory Support
- Perform literature screening and review for safety monitoring
- Apply regulatory intelligence and reporting requirements to safety activities
- Participate in audits and inspection readiness activities
- Collaboration & Communication
- Build professional working relationships with internal and external project teams
- Work collaboratively in team-based and independent environments
- Support multiple safety projects while maintaining timelines and accuracy
Educational Qualification
Candidates must possess one of the following:
- Bachelor’s degree in Life Sciences
- Equivalent combination of education and relevant experience
Experience Required
- 2–4 years of experience in ICSR case processing
- Experience handling:
- Spontaneous cases
- Clinical Trial (CT) cases
- Literature cases
- Mandatory experience in Post-Marketing Case Processing (CP)
Required Skills & Knowledge
- Strong understanding of pharmacovigilance and drug safety regulations
- Knowledge of:
- ICH-GCP
- GVP guidelines
- Clinical trial processes (Phases II–IV)
- Post-marketing safety requirements
- Familiarity with safety database systems and medical terminology
- Proficiency in Microsoft Office Suite and collaboration tools
- Excellent communication and interpersonal skills
- Strong organizational and multitasking abilities
- High attention to detail and accuracy
