Syneos Health Hiring for Safety PV Coordinator role at Syneos Health with responsibilities in safety submissions, compliance, and global PV operations.
Syneos Health, a globally recognized biopharmaceutical solutions organization, is inviting applications for the position of Safety & PV Coordinator for its Gurgaon (Gurugram) office. The role focuses on supporting pharmacovigilance (PV) submission activities and contributing to high-quality safety reporting within clinical research operations. This long-format job post provides an in-depth view of the company, job requirements, responsibilities, and career growth opportunities to help candidates understand the significance of this position. Syneos Health Hiring for Safety PV Coordinator
Syneos Health stands as one of the most respected and influential names in clinical development, medical affairs, and commercial solutions. With operations in more than 110 countries and a workforce of nearly 29,000 employees, the organization plays a vital role in accelerating drug development and supporting breakthrough therapies worldwide. Over the past five years, Syneos Health has partnered with 94% of all FDA-approved novel drugs, 95% of EMA-authorized products, and over 200 clinical studies across thousands of global sites. This demonstrates the company’s strong industry presence and commitment to excellence. Syneos Health Hiring for Safety PV Coordinator
The Safety & PV Coordinator role is designed for individuals who are detail-oriented, proactive, and well-versed in regulatory compliance related to drug safety. The position requires a strong understanding of pharmacovigilance processes, expedited and periodic safety reporting, SOP compliance, regulatory intelligence, and documentation standards. As part of a highly collaborative team, the selected candidate will support PV submissions and ensure the accurate tracking and forwarding of safety documentation. Syneos Health Hiring for Safety PV Coordinator
Key Highlights of the Safety & PV Coordinator Role
| Key Feature | Description |
|---|---|
| Job Title | Safety & PV Coordinator |
| Location | Gurgaon (Gurugram), India |
| Work Type | Full-time, Office-based |
| Company | Syneos Health |
| Primary Focus | Pharmacovigilance submission support |
| Key Skills Needed | Safety reporting, regulatory compliance, documentation, PV tracking |
| Industry | Biopharmaceutical, Clinical Research |
| Growth Potential | Strong training, career development, global exposure |
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical services organization purpose-built to accelerate customer success by combining clinical development, medical expertise, and commercialization strategies. Its unique model ensures that clients and patients remain at the heart of all operations. The organization emphasizes agility, innovation, and transparency, creating an environment that supports both employee growth and client satisfaction. Syneos Health Hiring for Safety PV Coordinator
Syneos Health is proud of its Total Self Culture, which encourages employees to bring their authentic selves to work. This culture celebrates diversity, equity, inclusion, and personal well-being. Whether employees join as part of a functional service provider team or through a full-service model, they receive access to development programs, technical training, peer recognition, and a supportive management structure. This makes Syneos Health a desirable workplace for professionals who seek long-term career progression. Syneos Health Hiring for Safety PV Coordinator
Detailed Job Description
The Safety & PV Coordinator plays a key role in pharmacovigilance operations by supporting the collection, preparation, submission, and tracking of safety data. The role demands accuracy, organization, and adherence to regulatory requirements. Below is a comprehensive overview of the core responsibilities expected in this role: Syneos Health Hiring for Safety PV Coordinator
1. Safety Submission Tracking
The coordinator will maintain accurate tracking of all safety submissions for assigned projects. This includes:
- Monitoring submission timelines
- Updating safety tracking systems
- Ensuring all documentation meets project- and regulatory-specific requirements
- Identifying delays or discrepancies and escalating when necessary
Accurate tracking allows Syneos Health to uphold compliance with global regulatory authority timelines.
2. Collaboration and Communication
A vital aspect of the job involves establishing constructive working relationships with:
- Internal team members
- External stakeholders
- Clients and regulatory bodies
The coordinator must maintain professional communication while ensuring clear, prompt information exchange to keep the project moving effectively.
3. Application of Regulatory Intelligence
Syneos Health maintains a database of updated regulatory intelligence related to global drug safety reporting requirements. The coordinator must:
- Apply regulatory insights to safety submission tasks
- Ensure all reporting aligns with relevant regulations, including ICH, GCP, FDA, EMA, and local guidelines
- Stay updated on evolving reporting standards
This guarantees that safety submissions are compliant, consistent, and globally accepted.
4. Documentation Filing and Management
The coordinator will be responsible for managing and organizing documentation in accordance with project standards. This includes:
- Filing documents electronically or in physical format
- Maintaining version control
- Ensuring accessibility for audits and project review
Proper documentation is essential for regulatory inspections, ongoing safety evaluations, and internal quality checks.
5. Support for Expedited and Periodic Reports
The role involves assisting in the preparation and assembly of:
- Expedited safety reports
- Periodic safety update reports (PSURs)
- Development safety update reports (DSURs)
- Other regulatory-required safety documentation
The coordinator may support formatting, assembling appendices, proofreading, and ensuring compliance with submission standards.
6. Miscellaneous Safety Reporting Support
Additional responsibilities may include:
- Supporting project-specific PV tasks
- Coordinating with cross-functional departments
- Managing communication logs and submission confirmations
This ensures smooth flow of information between all parties involved in pharmacovigilance reporting.
7. Forwarding Completed Safety Documents
Once safety submission documents are prepared and finalized, the coordinator must:
- Forward them to clients, health authorities, and other designated parties
- Ensure timely dissemination
- Maintain proof of submission
Timely forwarding is crucial for regulatory compliance and project success.
8. Compliance With SOPs and Guidelines
Candidates must maintain an in-depth understanding of:
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- ICH guidelines
- Good Clinical Practices (GCPs)
- Drug development and safety reporting processes
Strict adherence to these standards ensures high-quality work and aligns with global regulations. Syneos Health Hiring for Safety PV Coordinator
Why Work at Syneos Health?
Syneos Health offers a professional environment that encourages career advancement, innovation, and continuous learning. Employees receive: Syneos Health Hiring for Safety PV Coordinator
- Access to therapeutic area training
- Opportunities for global project exposure
- Strong leadership support
- Competitive rewards and recognition programs
- A workplace that prioritizes diversity and belonging
With an impressive track record of involvement in major drug approvals and global studies, Syneos Health provides unmatched opportunities for growth in pharmacovigilance and clinical research. Syneos Health Hiring for Safety PV Coordinator
Additional Information
Syneos Health emphasizes that the responsibilities listed above are not exhaustive. The company may assign other related duties depending on project requirements. The organization follows global employment policies and ensures compliance with:
- Hiring regulations
- The EU Equality Directive
- The Americans with Disabilities Act (ADA)
The company is committed to providing reasonable accommodations for employees and applicants when necessary. Syneos Health Hiring for Safety PV Coordinator
How to Apply
Interested candidates can apply for the Safety & PV Coordinator (PV Submission) role by visiting the official Syneos Health careers website: Syneos Health Hiring for Safety PV Coordinator
Apply here:
https://www.syneoshealth.com
(Navigate to the Careers section and search for Job Requisition ID: 25104098)
Submit your updated resume and complete the application form. Shortlisted candidates will be contacted by the recruitment team for further steps. Syneos Health Hiring for Safety PV Coordinator
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