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Safety & Pv Ops Specialist I

2+ years
INR 6–10 LPA
10 Aug. 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.