Syneos Health is hiring a Senior Safety & PV Operations Specialist with expertise in Argus Console and Periodic Reporting. This is a remote position with the hiring office located in Delhi/NCR. The role involves providing operational support in pharmacovigilance (PV), overseeing Argus Safety database functions, and ensuring compliance with global safety regulations.
📌 Job Type: Full-time
📍 Location: Remote (Hiring Office: Delhi/NCR)
💼 Experience: 5-10 years
🎓 Qualification: Bachelor’s degree in Life Sciences or related field
About Syneos Health
Syneos Health (NASDAQ: SYNH) is a leading fully integrated biopharmaceutical solutions organization. They partner with pharmaceutical and biotech companies to accelerate the development and commercialization of new therapies. With a strong global presence, Syneos Health combines clinical, medical, and commercial expertise to deliver innovative solutions.
🔹 Industry: Clinical Research, Pharmacovigilance, Biopharma
🔹 Company Size: 25,000+ employees
🔹 Reviews: 3.8/5 (Based on 28 reviews)
Job Description
Key Responsibilities
General PV Operations
- Develop and maintain Job Aids, SOPs, and process documents.
- Ensure compliance with FDA/EU/ICH guidelines for pharmacovigilance.
- Generate and analyze SPVG metrics for reporting.
Argus Console & Periodic Reporting (SME Role)
- Oversee PSURs, PBRERs, DSURs, line listings, and tabulations in Argus Safety.
- Troubleshoot case and report discrepancies in Argus.
- Collaborate with Medical Writing and cross-functional teams for report configurations.
- Participate in safety database migrations, validations, and audits.
Safety Systems & IT Support
- Administer and configure Argus Safety database per project requirements.
- Generate custom reports, listings, and queries for regulatory submissions.
- Provide training and mentorship to junior specialists.
- Assist in Veeva Vault Safety, ArisG, and other PV systems as needed.
Qualifications & Skills
✅ Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or Computer Science.
✅ 5+ years of experience in Pharmacovigilance & Argus Console operations.
✅ Expertise in Argus Periodic Reporting (PSURs, PBRERs, DSURs).
✅ Strong knowledge of ICH-GCP, FDA/EU PV regulations.
✅ Proficiency in Oracle, Crystal Reports, SQL, Business Objects (preferred).
✅ Excellent communication, organizational, and problem-solving skills.
