Pharmacovigilance Specialist Job in Pune Hyderabad at Syneos Health. Work on ICSR processing, literature review, and global drug safety operations in India.
Are you an experienced pharmacovigilance professional looking to grow in global drug safety operations? Syneos Health is hiring Safety & PV Specialist I across Pune, Gurugram, and Hyderabad. This opportunity is ideal for candidates with hands-on experience in literature case processing, ICSR workflows, and safety databases who want to work with a leading global CRO.
Company Overview
Syneos Health is a globally recognized contract research organization (CRO) providing integrated clinical development and commercialization services. The company partners with pharmaceutical and biotechnology firms to accelerate drug development and improve patient outcomes. Known for its strong pharmacovigilance capabilities, Syneos Health offers excellent career growth opportunities in drug safety and regulatory domains.
Job Overview
| Job Title | Safety & PV Specialist I |
|---|---|
| Company | Syneos Health |
| Location | Pune, Gurugram & Hyderabad, India |
| Employment Type | Full-Time |
| Department | Pharmacovigilance / Drug Safety |
| Experience | 1–4.5 Years |
| Qualification | B.Pharm / M.Pharm / MBBS / BDS / MDS |
| Work Mode | Hybrid |
| Openings | 10 Positions |
Job Location & Employment Type
- Work Locations: Pune, Gurugram, Hyderabad
- Job Type: Full-time (Permanent)
- Work Mode: Hybrid
Open Positions / Department Details
This role is part of the Pharmacovigilance and Drug Safety team, focusing on literature case processing, safety data management, and regulatory compliance.
Key Roles & Responsibilities
As a Safety & PV Specialist I, you will handle critical pharmacovigilance activities related to literature-based case processing.
Literature Case Processing
- Performing literature screening and case processing
- Identifying adverse events from scientific publications
- Conducting duplicate checks and case triage
ICSR & Safety Data Management
- Processing Individual Case Safety Reports (ICSRs)
- Entering safety data into databases such as:
- Argus Safety
- ARISg
- LifeSphere MultiVigilance (LSMV)
- Ensuring data accuracy and completeness
Regulatory Compliance
- Ensuring compliance with:
- ICH-GCP guidelines
- Pharmacovigilance regulations
- Maintaining quality standards and audit readiness
Medical Coding & Documentation
- Using MedDRA coding for adverse events
- Preparing safety documentation and reports
- Supporting regulatory submissions
Collaboration & Communication
- Working with cross-functional teams
- Supporting case processing and submission workflows
- Communicating with internal stakeholders
Eligibility Criteria
Educational Qualification
Candidates must have:
- B.Pharm / M.Pharm
- MBBS / BDS / MDS
- Or equivalent qualification
Experience Required
- 1 to 4.5 years of experience in:
- Pharmacovigilance
- Literature case processing
- Drug safety
- Preferred:
- 4–4.5 years of relevant experience
Skills Required
- Strong knowledge of:
- ICSR workflows
- Pharmacovigilance processes
- Hands-on experience with:
- Argus Safety Database
- ARISg
- LSMV
- Understanding of:
- MedDRA coding
- Medical terminology
- Good communication and analytical skills
- Attention to detail and compliance mindset
Preferred / Additional Skills
- Experience in global literature screening (EMA, PubMed)
- Knowledge of:
- CIOMS forms
- MedWatch
- XML submissions
- Familiarity with PV compliance metrics and quality checks
Salary & Benefits
- Salary will be as per company norms
- Additional benefits include:
- Hybrid work flexibility
- Exposure to global pharmacovigilance projects
- Career growth in drug safety and regulatory domains
- Learning and development opportunities
Selection Process
The hiring process may include:
- Resume screening
- HR discussion
- Technical interview (PV / Drug Safety)
- Final round
How to Apply
Interested candidates should apply through the official online application portal.
- Ensure your resume highlights PV experience and database skills
- Mention tools like Argus or LSMV clearly
Important Dates
- No fixed deadline mentioned
- Immediate joiners preferred
Why Apply for This Pharma Job?
This role provides strong growth in pharmacovigilance and global drug safety operations. Key benefits include:
- Work with a leading global CRO
- Gain expertise in literature case processing and ICSR workflows
- Exposure to international regulatory standards
- Opportunity to work with advanced PV databases
- Career progression in drug safety and risk management
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We are not affiliated with Syneos Health or any recruiter. We do not charge any fees for job applications. Candidates should verify details before applying.
Final Call-to-Action
If you have pharmacovigilance experience and want to grow in global drug safety operations, apply now and take your career to the next level.
