Pharmacovigilance Job at Syneos Health
Are you passionate about ensuring patient safety and compliance with global pharmacovigilance regulations? Syneos Health is seeking a dedicated Safety & Pharmacovigilance Specialist I in Hyderabad, India. This Pharmacovigilance Job in Hyderabad offers an opportunity to work on end-to-end ICSR processing and safety data management, contributing to the healthcare field. With a focus on Product Quality Complaint (PQC) case handling, this position is integral to maintaining regulatory standards and patient safety.
About Syneos Health:
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping them navigate complexity and accelerate progress. With a commitment to building an inclusive culture, Syneos Health emphasizes the importance of developing its people through career development, supportive management, and a total rewards program. The organization operates globally, ensuring that its teams are equipped to shape solutions that significantly impact healthcare.
Job Details:
- Job Title: Safety & Pharmacovigilance Specialist I
- Location: Hyderabad, India (Office-Based)
- Employment Type: Full-Time
- Experience Required: 2.5 – 4 Years
- Job Requisition ID: 25107951
- End Date: 06 August 2026 (1 day left to apply)
Job Description:
The Safety & Pharmacovigilance Specialist I is responsible for end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance regulations. This role requires demonstrated expertise in Product Quality Complaint (PQC) case handling and experience in medical research safety cases. Candidates will play a critical role in ensuring patient safety and regulatory compliance.
Key Responsibilities:
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
- Process ICSRs in accordance with Standard Operating Procedures (SOPs) and project/program-specific safety plans.
- Triage ICSRs and evaluate case data for completeness, accuracy, and regulatory reportability.
- Enter case data into the safety database (Argus / ARISg) in this Pharmacovigilance Job in Hyderabad.
- Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and relevant dictionaries.
- Prepare comprehensive and medically accurate narrative summaries at Syneos Health Careers.
- Identify missing or inconsistent information and follow up on queries until satisfactory resolution.
- Perform quality review of ICSRs.
Eligibility Criteria for the Pharmacovigilance Job:
- Education: PharmD / BDS / BMS / MBBS
- Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.
- Experience in handling medical research-related safety cases.
- Hands-on experience in Argus / ARISg safety database.
- Strong understanding of global pharmacovigilance regulations and reporting requirements.
- Knowledge of clinical trial phases II–IV and/or post-marketing safety.
- Proficiency in Microsoft Office applications.
