Apply for Safety PV Specialist I at Syneos Health India. Check eligibility, ICSR experience, responsibilities, salary details and apply online now today.
Introduction
If you have hands-on experience in pharmacovigilance and ICSR processing, this is a strong opportunity to advance your career. The Safety & PV Specialist I at Syneos Health role focuses on case processing, medical coding, and regulatory compliance in global drug safety operations. This position is ideal for professionals aiming to grow in clinical research and pharmacovigilance.
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 CRO that provides integrated clinical development and commercialization services. The company partners with pharmaceutical and biotech organizations to accelerate drug development and improve patient outcomes. With a strong presence worldwide, Syneos Health offers excellent career growth 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 case processing, regulatory reporting, and maintaining compliance across clinical and post-marketing programs.
Key Roles & Responsibilities
ICSR Processing & Case Handling
- Process Individual Case Safety Reports (ICSRs) as per SOPs
- Perform triage and evaluate cases for completeness and accuracy
- Enter safety data into databases and track case progress
Medical Coding & Narratives
- Perform MedDRA coding for adverse events and WHODrug coding
- Prepare detailed narrative summaries for safety cases
- Manage duplicate case identification and reconciliation
Regulatory Compliance & Reporting
- Support expedited reporting as per regulatory timelines
- Ensure compliance with ICH, GCP, and GVP guidelines
- Maintain documentation for TMF and PV systems
Literature Review & Data Management
- Conduct literature screening for safety signals
- Validate and maintain drug dictionaries and coding standards
- Support xEVMPD submissions and SPOR/IDMP activities
Quality & Audit Support
- Perform quality checks of ICSRs
- Participate in audits and inspections
- Maintain safety tracking 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
- (4+ years required for Safety & PV Specialist II level)
Skills Required
- Strong knowledge of pharmacovigilance processes
- Experience in ICSR processing and safety databases
- Familiarity with MedDRA and WHODrug coding
- Understanding of global regulatory requirements (ICH, GCP, GVP)
- Strong analytical and communication skills
- Attention to detail and quality focus
Salary & Benefits
- Salary: As per company standards
- Opportunity to work on global clinical projects
- Exposure to advanced pharmacovigilance systems
- Career growth in drug safety and clinical research
- Training and development programs
- Supportive and collaborative work environment
Selection Process
The recruitment process generally includes:
- Online application submission
- Resume shortlisting
- 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 expertise in end-to-end pharmacovigilance processes
- Exposure to global safety systems and regulatory standards
- Strong career growth in drug safety
- Opportunity to work on international projects
- Enhance skills in medical coding and case processing
FAQs
1. Who can apply for this job?
Candidates with relevant degrees and 2.6+ years of pharmacovigilance experience can apply.
2. Are B.Sc/M.Sc candidates eligible?
No, only B.Pharm, M.Pharm, BDS, BMS, or MBBS candidates are eligible.
3. What is the main responsibility?
ICSR processing, medical coding, and safety data management.
4. What experience is required?
Minimum 2.6 years of pharmacovigilance experience.
5. How can I apply for this job?
You can apply through the official Syneos Health careers website.
Conclusion
The Safety & PV Specialist I at Syneos Health role offers a great opportunity for pharmacovigilance professionals to grow in a global clinical research environment. With exposure to advanced safety systems, regulatory processes, and international projects, this role is ideal for building a strong career in drug safety. Apply now to move forward in your PV career.
Disclaimer
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