Are you an experienced Pharmacovigilance (PV) professional looking to step into a global clinical research environment? This could be your moment.
Syneos Health, a worldwide leader in biopharmaceutical solutions and clinical research services, is expanding its Safety & Pharmacovigilance teams in India. Openings are available at their Hyderabad and Gurugram offices, offering professionals the chance to work on global drug-safety programs with top pharmaceutical clients.
If patient safety, regulatory excellence, and high-impact work motivate you, this role places you exactly where science meets global health responsibility.
The Vital Role of Pharmacovigilance in Modern Medicine 💊
Pharmacovigilance is far more than case entry—it is the backbone of patient safety in the pharmaceutical industry.
PV professionals are responsible for:
- Detecting and assessing adverse drug reactions
- Preventing future safety risks
- Ensuring medicines remain safe throughout their lifecycle
At Syneos Health, Safety Specialists contribute directly to global regulatory decisions, helping protect millions of patients worldwide.
Working in a Contract Research Organization (CRO) environment also means exposure to multiple therapeutic areas—including oncology, neurology, vaccines, and rare diseases—accelerating your professional growth far faster than traditional pharma setups.
Key Job Responsibilities: What You’ll Do 📋
As a Safety & Pharmacovigilance Specialist, your responsibilities will include:
1. ICSR Case Triage & Processing
- Receive and process Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources
- Assess seriousness, expectedness, and causality of adverse events
2. Medical Coding (MedDRA & WHODrug)
- Code adverse events, medical history, and medications using MedDRA and WHODrug
- Ensure global standardization and regulatory accuracy
3. Safety Database Management
- Work hands-on with industry-leading databases such as Argus, ArisG, or LSMV
- Meet strict global regulatory timelines for case submissions
4. Regulatory & XEVMPD / SPOR Support
- Support XEVMPD (Article 57) submissions
- Participate in SPOR/IDMP activities to maintain EU medicinal product compliance
5. Quality & Documentation
- Maintain Trial Master File (TMF) and PV System Master File (PSMF)
- Ensure all activities are audit-ready and GVP-compliant
Who Should Apply? 🎓
This role is ideal for professionals who bring both experience and a quality-driven mindset.
Eligibility Criteria:
- Experience: 2.6 – 4.5 years in ICSR case processing
- Databases: Hands-on experience with Argus, ArisG, or LSMV
- Education:
- B.Pharm / M.Pharm
- Life Sciences
- Nursing
- MBBS / BDS / BHMS / BAMS
- Regulatory Knowledge: FDA, EMA, MHRA, ICH-GCP
- Skills:
- Strong narrative writing
- Attention to detail
- Ability to meet regulatory timelines ⏱️
Why Build Your Career at Syneos Health? 🏢✨
Choosing Syneos Health means choosing long-term career growth, not just a job.
What Sets Syneos Apart:
- Office-Based Learning: Collaborative work culture in Hyderabad & Gurugram
- Global Exposure: Work with Top 50 global pharmaceutical companies
- Continuous Learning: Advanced LMS with training in AI-driven PV & automation
- Career Progression:
Specialist → Senior Specialist → Lead → Safety Management / QA
Life at Syneos Health Locations 📍
Hyderabad
India’s Genome Valley, a major hub for pharma, biotech, and clinical research innovation.
Gurugram
A high-energy corporate ecosystem with world-class infrastructure and proximity to regulatory & industry leaders.
How to Apply 📧
Ready to take your Pharmacovigilance career global?
📨 Send your updated CV to:
agil.viswambharan@syneoshealth.com
📌 Subject Line:
Application for Safety & PV Specialist – [Years of Experience] – [Preferred Location]
⚠️ Roles at Syneos Health are highly competitive—early applications are strongly encouraged.
