Location: Gurugram, India – Hybrid
Safety & PV Ops Specialist I – Syneos Health
Syneos Health is seeking a Safety & Pharmacovigilance (PV) Operations Specialist I to support global drug safety operations, system configuration, training, and compliance. This role is ideal for candidates with knowledge of safety databases, PV processes, and regulatory guidelines who want to contribute to advancing patient safety in a fast-paced biopharmaceutical environment.
Responsibilities:
Develop and maintain safety and PV documentation including training records, project finance data, audit/inspection logs, and proposals.
Ensure compliance with FDA, EMA, and ICH safety regulations and Good Pharmacovigilance Practices (GVP).
Support Quality Planning, Compliance, and Assurance activities, including QC reviews, SOPs, and risk-based assessments.
Maintain audit and inspection readiness for pharmacovigilance projects.
Create and deliver PV training materials; oversee Learning Management System (LMS) activities for Safety & PV.
Configure, administer, and maintain Argus Safety database per project-specific requirements.
Troubleshoot issues in Argus and other safety systems; assist in system validations, testing, and data migrations.
Generate reports, listings, and queries from safety databases for internal, client, and regulatory purposes.
Support proposal development including RFP/RFI responses, budgets, and SPVG text/templates.
Collaborate with cross-functional project teams and represent safety systems in client and bid defense meetings.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or related field.
Strong knowledge of safety databases (Argus, ArisG, Clintrace) and medical terminology.
Familiarity with ICH guidelines, GVP, FDA, and EMA safety reporting regulations.
Proficiency in Microsoft Office Suite; SQL Plus, Business Objects, Crystal Reports, and Oracle Analytics preferred.
Clinical research or CRO experience with safety operations highly desirable.
Strong communication, presentation, and interpersonal skills.
Ability to manage multiple projects, prioritize tasks, and meet deadlines with high accuracy.
Detail-oriented with strong organizational and documentation skills.
Minimal travel up to 15%.
Perks & Benefits:
Competitive salary with performance-based rewards.
Hybrid working model offering flexibility and collaboration.
Access to cutting-edge PV systems and global safety projects.
Career development programs, mentoring, and professional training.
Inclusive culture focused on diversity, innovation, and recognition.
Company Overview:
Syneos Health is a global biopharmaceutical solutions leader with over 29,000 employees across 110 countries. Trusted by 94% of FDA-approved drugs and 95% of EMA-authorized products in the past five years, Syneos Health accelerates clinical development and pharmacovigilance excellence worldwide.
Work Model: Hybrid – Gurugram, India
Expected Salary: Industry range for Safety & PV Ops Specialists in India is approximately INR 6–10 LPA, depending on experience and technical expertise.
Apply now to join Syneos Health as a Safety & PV Ops Specialist I and play a vital role in ensuring patient safety and regulatory compliance in global clinical trials.
Gujarat :
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Siliguri |Illinois :
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