Apply for Safety PV Specialist I at Syneos Health India. Check eligibility, ICSR experience, responsibilities, salary details and apply online for this job today.
Introduction
If you have experience in pharmacovigilance and case processing, this is a strong opportunity to grow in a global CRO. The Safety & PV Specialist I at Syneos Health role focuses on ICSR processing, safety data management, and regulatory compliance. This position is ideal for professionals looking to advance their careers in drug safety and clinical research.
Job Overview
| Job Title | Safety & PV Specialist I |
|---|---|
| Company Name | Syneos Health |
| Location | Hyderabad / Gurugram / Pune |
| Employment Type | Full-Time (Office-Based) |
| Department | Pharmacovigilance / Drug Safety |
| Experience Required | 2.6+ Years |
| Education | B.Pharm / M.Pharm / BDS / BMS / MBBS |
| Salary | As per company standards |
Company Overview
Syneos Health is a leading global clinical research and life sciences services company. It supports pharmaceutical and biotech organizations throughout the drug development lifecycle, from clinical trials to commercialization. With a strong global presence and innovative approach, Syneos Health provides excellent opportunities in pharmacovigilance and clinical research.
Job Location & Employment Type
- Location: Hyderabad, Gurugram, Pune
- Employment Type: Full-Time (Office-Based)
- Work Mode: On-site
Open Positions / Department Details
This role is part of the Clinical Solutions – Pharmacovigilance team, responsible for safety data processing, regulatory reporting, and compliance activities across clinical and post-marketing programs.
Key Roles & Responsibilities
ICSR Processing & Case Management
- Process Individual Case Safety Reports (ICSRs) as per SOPs
- Perform triage and validate case data for completeness and accuracy
- Enter and manage data in safety databases
Medical Coding & Documentation
- Perform MedDRA coding for adverse events and WHODrug coding
- Prepare narrative summaries for safety cases
- Handle duplicate case identification and reconciliation
Regulatory Reporting & Compliance
- Support expedited reporting as per global regulations
- Ensure compliance with ICH, GCP, and GVP guidelines
- Maintain documentation for TMF and safety systems
Literature & Data Review
- Conduct literature screening for safety information
- Review and validate safety data
- Support xEVMPD submissions and SPOR/IDMP activities
Quality & Audit Support
- Perform quality checks of safety cases
- Participate in audits and inspections
- Maintain tracking systems and documentation accuracy
Eligibility Criteria
Education
- B.Pharm / M.Pharm / BDS / BMS / MBBS
- Note: B.Sc / M.Sc candidates are not eligible
Experience
- Minimum 2.6+ years of pharmacovigilance experience (ICSR processing)
Skills Required
- Strong knowledge of pharmacovigilance and ICSR workflows
- Experience with safety databases and coding dictionaries (MedDRA, WHODrug)
- Understanding of global regulatory requirements (ICH, GCP, GVP)
- Good analytical and problem-solving skills
- Strong communication and documentation skills
- Attention to detail and quality focus
Salary & Benefits
- Salary: As per company standards
- Opportunity to work with global clinical projects
- Exposure to advanced PV systems and regulatory processes
- Career growth in pharmacovigilance and drug safety
- Learning and development programs
- Supportive and collaborative work environment
Selection Process
The hiring process generally includes:
- Online application submission
- Resume screening
- Technical interview (PV + Case Processing)
- HR discussion
- Final selection
How to Apply
Candidates interested in the Safety & PV Specialist I at Syneos Health role can apply through the official Syneos Health careers portal. Immediate joiners are preferred.
Important Dates
- Apply as soon as possible (no fixed deadline mentioned)
Why Apply for This Job?
- Work with a globally recognized CRO
- Gain experience in end-to-end pharmacovigilance processes
- Exposure to global regulatory standards and safety systems
- Strong career growth in drug safety and clinical research
- Opportunity to work on international projects
- Enhance expertise in ICSR processing and medical coding
FAQs
1. Who can apply for this job?
Candidates with B.Pharm, M.Pharm, BDS, BMS, or MBBS and 2.6+ years PV experience can apply.
2. Are B.Sc/M.Sc candidates eligible?
No, B.Sc and M.Sc candidates are not eligible for this role.
3. What is the main responsibility?
The primary responsibility is ICSR processing and pharmacovigilance case management.
4. What is the required experience?
Minimum 2.6 years of pharmacovigilance experience is required.
5. How can I apply for this job?
You can apply online through the official Syneos Health careers website.
Conclusion
The Safety & PV Specialist I at Syneos Health role is an excellent opportunity for pharmacovigilance professionals to advance their careers in a global CRO environment. With exposure to international safety processes, regulatory compliance, and advanced systems, this role offers strong professional growth. Apply now to take the next step in your PV career.
Disclaimer
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