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Pv Associate/Sr. Pv Associate

1-3 years
Not Disclosed
4 July 1, 2025
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, BDS, MBBS, BHMS, BAMS, MScq 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

 

PV Associate / Sr. PV Associate – Delhi / US

Location: Delhi, India / United States
Experience: 1–3 years
Job Type: Full-time


Job Summary

We are hiring Pharmacovigilance (PV) Associates and Senior PV Associates to support global drug safety operations in Delhi and the US. This role focuses on the end-to-end processing of individual case safety reports (ICSRs), ensuring compliance with regulatory and pharmacovigilance standards. Ideal for professionals with 1–3 years of PV experience, this opportunity offers growth in a fast-paced, global regulatory environment.


Key Responsibilities

  • Perform triage, data entry, narrative writing, coding (MedDRA), and quality review of ICSRs

  • Ensure timely and accurate case processing per regulatory timelines

  • Support expedited and periodic safety reporting (e.g., PBRERs, DSURs)

  • Maintain compliance with global PV guidelines (ICH-GCP, GVP, FDA, EMA)

  • Collaborate with cross-functional teams for case follow-up and reconciliation

  • Escalate potential safety signals or product quality issues

  • Ensure documentation is maintained according to SOPs and quality standards

  • Contribute to audits, inspections, and CAPA implementation


Required Skills & Qualifications

  • Life sciences degree (B.Pharm, M.Pharm, BDS, MBBS, BHMS, BAMS, MSc, etc.)

  • 1–3 years of pharmacovigilance experience in case processing

  • Working knowledge of MedDRA, WHO-DD, and PV databases (e.g., Argus, ARISg)

  • Familiarity with ICH-GCP, GVP, FDA, and EMA regulations

  • Strong narrative writing and medical coding skills

  • Excellent communication and documentation abilities

  • Attention to detail and strong time management


Perks & Benefits

  • Competitive salary based on experience and role level

  • Global exposure to regulatory safety processes and standards

  • Training and upskilling opportunities in drug safety and compliance

  • Performance-based bonuses and growth pathways

  • Health and wellness benefits (region-specific)

  • Work-life balance with structured support and guidance


Company Description

Join a leading global pharmaceutical and healthcare company known for its innovation in pharmacovigilance, clinical safety, and regulatory compliance. With operations in both India and the US, the company delivers cutting-edge solutions that support patient safety worldwide.


Work Mode: On-site or Hybrid (Delhi or US office depending on role)


Call-to-Action

Are you ready to grow your pharmacovigilance career in a dynamic and compliant environment?
Apply now for the PV Associate or Sr. PV Associate role and make a meaningful impact in global drug safety.

For more pharma and healthcare opportunities, visit ThePharmaDaily.com.