Syneos Health
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Safety & PV Specialist I – Literature Review
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Syneos Health is hiring a Safety & PV Specialist I – Literature Review in Gurugram, India. This is a full-time, office-based opportunity for candidates with a bachelor's degree in Pharmacy, Life Sciences, Nursing, or another relevant discipline. The role focuses on pharmacovigilance activities including literature screening, ICSR processing, safety database management, MedDRA and drug coding, duplicate case management, quality review, and regulatory safety reporting. Candidates should have knowledge of pharmacovigilance, medical terminology, safety databases, ICH-GCP, GVP, and applicable safety regulations. Experience or knowledge of xEVMPD, SPOR, IDMP, TMF, and PSMF activities may also be relevant.
Job Overview
| Particulars | Details |
|---|---|
| Position | Safety & PV Specialist I – Literature Review |
| Company | Syneos Health |
| Location | Gurugram |
| Job Type | Full-Time |
| Category / Department | IT |
| Application Mode | Online |
🏢 About Syneos Health
Company Overview:
Syneos Health is a global, fully integrated life sciences services organization supporting pharmaceutical and biotechnology companies across drug development and commercialization. Its Clinical Solutions teams work across clinical development and drug development programs, supporting complex research and safety activities across global markets.
Company Mission:
Not Provided
Company Vision:
Not Provided
Core Values / Principles
Employee Development
Career Progression
Quality and Compliance
Collaboration
Global Life Sciences Expertise
🌐
Company Website
📍
Office Location
Not Provided
💡 Editor's Note / Preparation Tip
Resume Tips:
Highlight pharmacovigilance, drug safety, and literature-review experience.
Clearly mention ICSR processing and safety database experience.
Showcase knowledge of MedDRA, medical terminology, drug coding, and case narratives.
Include exposure to ICH-GCP, GVP, clinical trial safety, or post-marketing safety.
Mention experience with quality review, regulatory reporting, and safety documentation.
Include relevant pharmacy, life sciences, nursing, biotechnology, or clinical research qualifications.
Interview Preparation:
Review the complete ICSR processing lifecycle.
Prepare for questions about literature screening and identification of reportable safety information.
Revise MedDRA coding, drug coding, duplicate case management, and case narratives.
Understand expedited safety reporting and regulatory requirements.
Review ICH-GCP and GVP principles.
Be familiar with clinical trial and post-marketing pharmacovigilance processes.
Prepare to discuss quality checks, follow-up queries, and safety database workflows.
Review concepts related to xEVMPD, SPOR, IDMP, TMF, and PSMF.
Professional Tips:
Emphasize accuracy, regulatory compliance, and attention to detail.
Use pharmacovigilance terminology appropriately throughout your resume.
Quantify relevant workload or quality achievements where applicable.
Highlight experience working with global teams and cross-functional stakeholders.
Tailor your resume specifically toward literature review and safety operations.
📝 Job Description
Position Details:
The Safety & PV Specialist I – Literature Review will support pharmacovigilance and drug safety operations, with a particular focus on literature screening and review. The role involves processing and evaluating Individual Case Safety Reports (ICSRs), entering safety information into relevant systems, performing medical and drug coding, preparing case narratives, managing follow-up activities, and supporting regulatory safety reporting.
The selected candidate will also contribute to quality review, duplicate case identification, safety tracking, documentation, and compliance with applicable SOPs, ICH guidelines, GCP, GVP, global safety regulations, and project-specific requirements.
Additional responsibilities may include xEVMPD product-record validation and submission support, SPOR and IDMP activities, manual recoding of product and substance terms, and maintenance of clinical safety documentation in TMF or PSMF systems.
Benefits / Compensation
Career development and progression opportunities
Technical and therapeutic-area training
Supportive line management
Peer recognition programs
Exposure to global drug development and pharmacovigilance activities
Collaboration with multidisciplinary life sciences teams
Experience with clinical and post-marketing safety processes
Benefits and employment terms may vary according to company policy, location, and individual employment conditions.
Candidate Requirements:
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or another relevant discipline, or an equivalent combination of education and experience.
Relevant backgrounds may include B.Pharm, Pharm.D, B.Sc Nursing, B.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, or closely related life science disciplines.
Knowledge of pharmacovigilance and drug safety.
Understanding of ICSR processing and safety databases.
Knowledge of literature screening and review.
Understanding of medical terminology and safety reporting processes.
Ability to perform documentation and quality review activities.
Ability to manage time and priorities effectively.
Preferred Skills:
Pharmacovigilance and Drug Safety
Literature Review
ICSR Processing
MedDRA Coding
Drug Coding and Drug Dictionaries
Safety Case Narratives
Expedited Safety Reporting
Clinical Trial and Post-Marketing Safety
ICH-GCP and GVP
xEVMPD, SPOR, and IDMP
TMF and PSMF
Microsoft Word, Excel, and PowerPoint
Working Days & Hours:
Not Provided
How to Apply:
Candidates can apply through the Syneos Health Workday job portal using the provided vacancy link.
🎯 Key Responsibilities
- ✓ Enter and track safety information related to Individual Case Safety Reports (ICSRs).
- ✓ Support ICSR processing according to applicable SOPs and project-specific safety plans.
- ✓ Perform ICSR triage and assess cases for completeness, accuracy, and regulatory reportability.
- ✓ Enter relevant case information into safety databases.
- ✓ Perform coding of adverse events, medical history, medications, tests, and other medical information.
- ✓ Prepare accurate and complete safety case narratives.
- ✓ Identify missing case information and generate follow-up queries when required.
- ✓ Support expedited safety-report submissions according to applicable regulatory requirements.
- ✓ Perform pharmacovigilance literature screening and literature review.
- ✓ Perform drug coding and maintain drug dictionaries.
- ✓ Conduct MedDRA coding when required.
- ✓ Support xEVMPD product-record validation and submission activities.
- ✓ Perform manual recoding of un-recoded product and substance terms.
- ✓ Identify and manage duplicate ICSRs.
- ✓ Support SPOR and IDMP-related activities.
- ✓ Perform quality reviews of ICSRs.
- ✓ Maintain relevant clinical safety documentation in TMF or PSMF systems.
- ✓ Maintain compliance with SOPs, ICH guidelines, GCP, GVP, global regulations, and project requirements.
- ✓ Support audits and apply relevant regulatory intelligence to safety activities.
- ✓ Maintain effective working relationships with internal and external stakeholders.
💡 Required Qualifications & Skills
✓ Pharmacovigilance
✓ Drug Safety
✓ Literature Screening and Review
✓ ICSR Processing
✓ Safety Databases
✓ Medical Terminology
✓ MedDRA Coding
✓ Drug Coding
✓ Safety Case Narratives
✓ Expedited Safety Reporting
✓ Clinical Trial Safety
✓ Post-Marketing Pharmacovigilance
✓ ICH-GCP
✓ GVP
✓ Safety Regulations
✓ Documentation and Quality Review
✓ Microsoft Word, Excel, and PowerPoint
✓ Time and Priority Management
🚀 Career Guidance & Interview Insights
To help you succeed, we've compiled original preparation guides, resume keywords, and growth analytics for this category of role.
Joining as a Safety & PV Specialist I – Literature Review offers a fantastic opportunity to work at the forefront of technological innovation. You will be exposed to modern software development lifecycles, collaborate with cross-functional product teams, and design scalable architectures that directly impact end-users. The continuous learning curve in tech ensures that your programming, debugging, and system engineering skills remain highly marketable and sharp.
Expected Career Progression Roadmap:
The career roadmap in technology is highly rewarding. Typical progression starts as a Junior Software Engineer, moving to Associate Developer and then Senior Software Engineer (3-6 years). From there, professionals choose between an individual contributor track—becoming a Tech Lead, Staff Engineer, and Principal Architect—or a management track, advancing to Engineering Manager, Director of Engineering, and Chief Technology Officer (CTO).
Expected Technical & Behavioral Questions:
- Q1: How do you optimize database query performance?
Answer Tip: Talk about indexing strategies, query execution plan analysis, avoiding N+1 queries, and implementing caching layers (like Redis). - Q2: Explain the differences between Microservices and Monolithic architecture.
Answer Tip: Highlight scaling advantages, loose coupling, independent deployments, network latency considerations, and data consistency challenges in microservices. - Q3: How do you handle merge conflicts in Git?
Answer Tip: Explain checking out the local branch, pulling the latest main branch, running git merge, opening the conflicted files to resolve blocks manually, and committing the resolved merge.
💡 Pro-Tip: Before your interview, research the company's recent news, product launches, and Glassdoor work reviews. Prepare 2-3 thoughtful questions for the interviewer regarding team dynamics and success metrics for this role.
To pass automated ATS (Applicant Tracking System) screening and catch the recruiter's eye, tailor your resume with the following tips:
- Keywords to include: Software Engineering, SDLC, OOP, CI/CD Pipelines, SQL databases, Agile, Unit Testing, Code Review, Cloud Architectures (AWS/Azure).
- Format: Use a clean, single-column resume format. Avoid graphics, text boxes, or tables which can scramble ATS parser outputs.
- Quantify Results: Instead of writing 'wrote code', write 'Developed a caching system that reduced server response times by 35%.'
Estimated Market Compensation in India:
Estimated compensation for this role type in India is ₹3,50,000 - ₹6,00,000 per annum (Freshers/Entry level). The actual salary package offered depends on factors such as company size, work mode (remote or on-site), individual technical proficiency, and negotiations during final HR rounds.
Suggested Professional Certifications:
Highly recommended certifications include: AWS Certified Solutions Architect, Microsoft Certified: Azure Fundamentals, Certified Kubernetes Administrator (CKA), Oracle Certified Professional Java SE, or tech-stack specific achievements (e.g. Meta Front-End Developer certification).
Frequently Asked Questions
What is the job title?
The position is Safety & PV Specialist I – Literature Review.
Which company is hiring for this role?
Syneos Health is hiring for this position.
Where is the job located?
The position is based in Gurugram, India.
Is this a remote position?
No. The supplied information specifies that the position is office-based.
What type of employment is offered?
The vacancy is described as a full-time position.
What educational qualification is required?
A bachelor's degree in Life Sciences, Pharmacy, Nursing, or another relevant discipline is required, or an equivalent combination of education and experience.
What pharmacy and life-science qualifications may be relevant?
Relevant backgrounds include B.Pharm, Pharm.D, B.Sc Nursing, B.Sc/M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, and closely related disciplines.
What are the key pharmacovigilance responsibilities?
The role includes literature review, ICSR processing, safety database activities, MedDRA and drug coding, case narratives, duplicate management, quality review, and regulatory safety reporting.
Is prior work experience specified?
The supplied vacancy information does not provide a specific minimum or maximum experience requirement.
How can candidates apply?
Candidates can apply through the Syneos Health Workday job portal using the vacancy application link provided in the job post.
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