Syneos Health Hiring Safety & PV Specialist I | Pharmacovigilance Jobs 2026
Syneos Health is hiring experienced Pharmacovigilance professionals for the position of Safety & PV Specialist I. This role offers exposure to global drug safety operations, ICSR processing, MedDRA coding, regulatory reporting, literature review, and pharmacovigilance compliance activities.
📋 Job Overview
| Details | Information |
|---|---|
| Position | Safety & PV Specialist I |
| Company | Syneos Health |
| Location | Gurugram / Hyderabad |
| Work Mode | Office Based |
| Shift | Night Shift |
| Experience | Minimum 2.6 Years |
| Employment Type | Full-Time |
🏢 About Syneos Health
Syneos Health is a leading global biopharmaceutical solutions organization supporting pharmaceutical, biotechnology, and medical device companies across clinical development, commercialization, and healthcare innovation.
With over 25,000 professionals globally, Syneos Health has contributed to numerous FDA-approved and EMA-authorized therapies while providing world-class clinical research and pharmacovigilance services.
🎯 Key Responsibilities
- Process Individual Case Safety Reports (ICSRs).
- Review and triage adverse event reports.
- Perform MedDRA coding and drug coding activities.
- Prepare detailed case narratives.
- Support expedited regulatory safety reporting.
- Manage duplicate case reconciliation.
- Perform literature screening and surveillance activities.
- Support xEVMPD validation and product submissions.
- Assist with SPOR and IDMP-related activities.
- Conduct quality reviews of safety cases.
- Maintain compliance with GVP, ICH-GCP, and regulatory requirements.
- Support audits, inspections, and quality initiatives.
🎓 Educational Qualification
- B.Pharm
- M.Pharm
- BDS
- BMS
- MBBS
Note: B.Sc and M.Sc candidates are not eligible for this position.
💼 Experience Required
- Minimum 2.6 years of Pharmacovigilance experience.
- Experience in ICSR processing.
- Safety database experience preferred.
- Experience with MedDRA coding.
- Regulatory reporting experience preferred.
- Immediate joiners preferred.
⭐ Preferred Skills
- Pharmacovigilance Case Processing
- Drug Safety Operations
- ICSR Lifecycle Management
- MedDRA Coding
- Safety Databases
- Literature Review
- Signal Detection Support
- Regulatory Compliance
- Quality Review of Safety Cases
- GVP & ICH Guidelines
- Documentation Skills
- Communication Skills
🎁 Why Join Syneos Health?
- Work with a leading global CRO and biopharmaceutical solutions company.
- Exposure to global Pharmacovigilance and Drug Safety projects.
- Opportunity to work with international pharmaceutical and biotech clients.
- Career growth in Safety Operations and Regulatory Compliance.
- Continuous learning and development programs.
- Advanced training in Drug Safety and Case Processing.
- Inclusive and collaborative work culture.
- Recognition and rewards programs.
- Long-term career opportunities within global healthcare organizations.
📈 Career Path in Pharmacovigilance
- Safety & PV Specialist I
- Senior Drug Safety Associate
- Drug Safety Specialist
- Senior Pharmacovigilance Specialist
- Pharmacovigilance Lead
- Safety Scientist
- Global Safety Manager
- Associate Director – Pharmacovigilance
- Director – Drug Safety & Risk Management
📄 ATS Resume Tips
- Include Pharmacovigilance, ICSR Processing, MedDRA Coding, Literature Review, Drug Safety, and Regulatory Reporting keywords.
- Highlight experience with safety databases such as Argus, ArisG, or similar platforms.
- Mention case volume handled and quality metrics achieved.
- Include experience with expedited reporting and follow-up activities.
- Show familiarity with GVP, ICH-GCP, and regulatory requirements.
- Keep resume ATS-friendly with clear headings and measurable achievements.
🎯 Interview Preparation Tips
- Revise end-to-end ICSR processing workflow.
- Review seriousness, expectedness, and causality concepts.
- Understand MedDRA hierarchy and coding principles.
- Practice narrative writing and case assessment.
- Review literature screening processes.
- Understand expedited reporting timelines.
- Prepare examples of quality review and reconciliation activities.
- Be ready to discuss PV regulations and compliance requirements.
❓ Common Interview Questions
- Explain the lifecycle of an ICSR.
- What is MedDRA and why is it used?
- What is the difference between serious and non-serious adverse events?
- How do you perform duplicate case reconciliation?
- What are expedited reporting timelines?
- How do you conduct literature screening?
- What is signal detection in Pharmacovigilance?
- What challenges have you faced during case processing?
- What PV databases have you worked on?
- Why do you want to join Syneos Health?
📚 Recommended Resources
📝 How to Apply
- Review the complete job description carefully.
- Update your resume with Pharmacovigilance and Drug Safety experience.
- Highlight ICSR processing, MedDRA coding, and safety database expertise.
- Mention regulatory reporting and literature review experience.
- Apply through the official Syneos Health careers portal.
Ensure your Pharmacovigilance experience aligns with the role requirements. Candidates with hands-on experience in case processing, coding, safety databases, and regulatory compliance will have a stronger profile for this opportunity.
