Safety & PV Ops Specialist I – Pune (Hybrid), India
Syneos Health® is seeking a Safety & PV Ops Specialist I in Pune (Hybrid) to provide essential support across pharmacovigilance, safety systems, compliance, and operational excellence. This role is ideal for professionals with a background in life sciences, pharmacy, nursing, or computer science who want to contribute to global drug safety operations within a leading biopharmaceutical solutions organization.
Expected Salary: For Safety & PV Ops Specialist roles in Pune, the industry average is INR 6–10 LPA, based on skills and experience.
This position supports the Safety & Pharmacovigilance Business Unit (BU) by maintaining compliance, developing training, supporting Argus Safety systems, and collaborating in proposal development to drive operational success.
Key Responsibilities
Maintain documentation, departmental metrics, and PV repositories.
Support compliance, quality assurance, and inspection readiness activities.
Develop and deliver training materials; manage the Learning Management System (LMS).
Configure, administer, and troubleshoot Argus Safety database and other safety systems.
Generate, validate, and QC safety database reports for regulatory, client, and internal use.
Contribute to proposal development, budget input, and RFP/RFI strategy.
Collaborate with cross-functional teams to ensure accurate and timely project delivery.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related field.
Proficiency in Safety Databases (Argus, ArisG, Clintrace) and medical terminology.
Strong knowledge of ICH-GCP, FDA, EMA, and global PV guidelines.
Technical expertise in SQL, Oracle, Business Objects, and Microsoft Office Suite.
Excellent organizational, documentation, and multi-tasking abilities.
Strong communication and presentation skills.
CRO or pharmaceutical industry experience preferred.
Perks & Benefits
Competitive salary with career growth opportunities.
Access to global pharmacovigilance training and development programs.
Work in a hybrid model with flexibility.
Inclusive Total Self culture, encouraging authenticity and collaboration.
Be part of a team contributing to 94% of FDA-approved novel drugs in the last 5 years.
About Syneos Health
Syneos Health® partners with leading global pharma and biotech companies, supporting over 200 studies, 73,000+ sites, and 675,000+ patients worldwide. With 29,000 employees across 110 countries, we are redefining biopharmaceutical solutions by combining insights, expertise, and innovation.
Work Mode: Hybrid (Pune, India)
If you’re ready to build a career in drug safety and pharmacovigilance with a global leader, apply today. At Syneos Health, Work Here Matters Everywhere.
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