Pharmacovigilance Job at Syneos Health in India
Looking to build a career in Pharmacovigilance with a global CRO? This Safety & PV Specialist I role at Syneos Health offers hands-on experience in drug safety and clinical research. You will work on adverse event reporting, ICSR processing, and regulatory compliance. The position is ideal for life sciences and medical graduates with experience in pharmacovigilance. This Pharmacovigilance Job at Syneos Health Careers in India provides exposure to global drug development and safety monitoring systems.
About the Company:
Syneos Health is a leading, fully integrated life sciences services organization that supports drug development and commercialization. With over 25,000 employees globally, the company partners with innovators across the pharmaceutical and biotechnology industries. Syneos Health has contributed to 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years, demonstrating its strong impact on global healthcare and clinical research.
Job Details:
- Role: Safety & PV Specialist I
- Location: Hyderabad / Gurugram / Pune
- Job ID: 25106472
- Work Type: Full-time (Office-based)
- Experience Required: Safety & PV Specialist I: Minimum 2.6 years
- Preference: Immediate joiners
Key Responsibilities:
- Enter and manage data in PVG quality and tracking systems
- Process Individual Case Safety Reports (ICSRs) as per SOPs
- Perform triage and evaluate ICSR data for accuracy and completeness
- Code medical events, medications, and history using MedDRA
- Compile narrative summaries and follow up on queries
- Generate timely and accurate safety reports as per regulatory requirements
- Conduct literature screening and safety reviews
- Handle duplicate ICSR identification and management
- Perform xEVMPD submissions and drug coding activities
- Maintain safety tracking and documentation at Syneos Health Careers
- Ensure compliance with SOPs, GCP, ICH, and GVP guidelines
- Support audits and maintain Trial Master File (TMF) documentation
- Collaborate with internal and external stakeholders
Educational Requirements for this Job:
B. Pharm / M. Pharm
Skills Required:
- Strong knowledge of pharmacovigilance and drug safety processes
- Experience in ICSR processing and safety databases
- Knowledge of MedDRA coding and regulatory guidelines
- Understanding of GCP, ICH, and GVP standards
- Attention to detail and data accuracy
- Analytical and problem-solving skills
- Ability to work in a team and manage deadlines
- Good communication and documentation skills
Benefits of the Pharmacovigilance Job:
- Career growth and development opportunities
- Technical and therapeutic area training programs
- Inclusive and supportive work culture
- Recognition and reward programs
- Opportunity to work on global clinical trials and drug safety projects
- Exposure to international regulatory standards
- Work with a leading CRO shaping the future of healthcare
Additional Information:
- The work environment includes collaboration with global teams
- Tasks and responsibilities may evolve based on business needs
- The company ensures compliance with global employment and equality regulations
- Reasonable accommodations are provided in accordance with applicable laws.
