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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 – Gurugram, India

Join Syneos Health® as a Safety & PV Ops Specialist I and contribute to advancing drug safety and pharmacovigilance operations within a global biopharmaceutical leader. Based in Gurugram, India, this role provides operational support in document management, compliance, safety systems, training, and proposal development, ensuring high-quality delivery across Safety & Pharmacovigilance projects.

Expected Salary: Industry standard range for Safety & PV Ops Specialist roles in India is INR 6–10 LPA, depending on experience.

As part of Syneos Health’s Safety & Pharmacovigilance Business Unit, you’ll collaborate with cross-functional teams to manage safety systems (Argus, ArisG, Clintrace), support audits and inspections, provide training, and contribute to proposals while ensuring adherence to ICH-GCP, FDA, EMA, and PV guidelines.

Key Responsibilities

  • Maintain safety and pharmacovigilance documentation, metrics, and quality systems.

  • Support compliance activities, audits, and inspection readiness.

  • Develop, track, and deliver safety-related training programs and materials.

  • Configure, validate, and maintain safety systems such as Argus and reporting tools.

  • Generate and QC safety database reports for regulatory and client use.

  • Contribute to proposals, budgets, and strategy development for Safety & PVG projects.

  • Collaborate with project managers and leadership teams to meet business targets.

Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related field.

  • Hands-on experience with Argus Safety, ArisG, Clintrace, or sponsor-specific safety systems.

  • Strong knowledge of ICH-GCP, GVP, FDA/EU safety regulations, and MedDRA terminology.

  • Proficiency in Oracle, SQL, Business Objects, and Microsoft Office Suite.

  • Ability to manage multiple projects with strong organizational and documentation skills.

  • Excellent written and verbal communication, presentation, and interpersonal abilities.

  • Prior CRO/pharma industry experience preferred.

Perks & Benefits

  • Competitive compensation and performance-driven rewards.

  • Career progression with technical and therapeutic training opportunities.

  • Global exposure across diverse therapeutic areas and innovative projects.

  • Flexible work culture with opportunities for remote collaboration.

  • Total Self culture promoting diversity, inclusion, and employee well-being.

About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization operating across 110 countries with over 29,000 employees. Partnering with leading pharma and biotech companies, Syneos Health has supported 94% of FDA-approved novel drugs in the last five years and is recognized for accelerating clinical development and enhancing patient outcomes.

Work Mode: Hybrid (Gurugram, India)

If you’re passionate about drug safety, pharmacovigilance operations, and global healthcare innovation, apply now and become part of a team where Work Here Matters Everywhere.