Syneos Health, a global leader in biopharmaceutical solutions, is seeking passionate professionals for the role of Safety & Pharmacovigilance (PV) Operations Specialist I across multiple locations in India, including Gurugram, Hyderabad, Pune, and Salem (hybrid and remote options available).
This is a unique opportunity to accelerate your career in drug safety, pharmacovigilance operations, and regulatory compliance with a company that has supported 94% of all FDA-approved novel drugs in the past five years.
📌 Job Responsibilities
As a Safety & PV Ops Specialist I, you will:
- Maintain safety and pharmacovigilance documentation, proposals, training records, and audit/inspection readiness.
- Support quality planning, compliance, and assurance by preparing controlled documents, metrics, and process assessments.
- Plan, develop, and deliver PV-specific training materials; manage the Learning Management System (LMS).
- Participate in safety system implementation, validation, testing, and reporting (Argus Safety, ArisG, Clintrace).
- Configure and troubleshoot safety databases, create custom reports, and assist with safety data migrations.
- Support business development by preparing proposals, budgets, and RFP/RFI responses.
- Collaborate with cross-functional teams to ensure compliance with ICH, FDA, EMA, and GCP regulations.
🎓 Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related field.
- Knowledge of safety databases (Argus Safety, Oracle, Business Objects, SQL) and medical terminology.
- Familiarity with ICH guidelines, FDA/EU regulations, pharmacovigilance processes.
- Strong computer proficiency (MS Office, relational databases).
- Excellent organizational, documentation, and presentation skills.
- Ability to manage multiple projects, prioritize tasks, and work independently or in teams.
🌟 Benefits of Working at Syneos Health
- Global exposure to cutting-edge pharmacovigilance systems.
- Structured career development and training programs.
- Inclusive Total Self Culture, promoting diversity and authenticity.
- Competitive salary with hybrid/remote flexibility.
- Opportunity to contribute to life-changing therapies worldwide.
📍 Job Locations
- Gurugram (Hybrid)
- Hyderabad (Hybrid/Office)
- Pune (Hybrid/Office)
- Salem (Hybrid/Office)
- Remote (Pan-India)
💰 Salary Range
INR 4,00,000 – 6,00,000 per annum (based on experience and location).
📝 How to Apply
