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Safety Physicians

1-3 years
Not Disclosed
3 July 1, 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

 

Manager – Pharmacovigilance

Location: Delhi, India
Experience Required: 5–6 Years
Job Type: Full-Time
Work Mode: On-site


Job Summary

A leading pharmaceutical organization is hiring a Pharmacovigilance Manager to lead drug safety and compliance activities in Delhi. The ideal candidate will bring deep expertise in case processing, MedDRA coding, ICH-GCP guidelines, and global PV regulations. This mid-level leadership role involves managing safety databases, ensuring regulatory compliance, and leading PV team performance for global markets.


Key Responsibilities

  • Manage end-to-end pharmacovigilance activities, including case intake, triage, processing, and medical coding

  • Lead timely and compliant ICSR submissions to global health authorities (FDA, EMA, MHRA, CDSCO)

  • Monitor PV team workflows, provide training, and ensure quality compliance

  • Maintain and optimize safety databases like Argus or ARISg

  • Review case narratives, assess seriousness and expectedness using global labelings (e.g., Company Core Data Sheet)

  • Support signal detection, aggregate reports (DSUR, PSUR), and safety review boards

  • Oversee SOPs and ensure continuous improvement in pharmacovigilance processes

  • Collaborate with medical writing, regulatory affairs, clinical, and QA teams

  • Handle audit and inspection readiness including CAPA implementation


Required Skills & Qualifications

  • Bachelor's or Master’s degree in Pharmacy, Life Sciences, or Medicine

  • 5–6 years of hands-on experience in Pharmacovigilance

  • Strong understanding of MedDRA coding, WHO-DD, ICH-GCP, GVP, and regulatory guidelines

  • Experience in case processing and safety databases (e.g., Argus, ARISg)

  • Familiarity with regulatory submissions and compliance standards

  • Excellent written and verbal communication skills

  • Ability to lead, train, and manage small teams effectively

  • Detail-oriented with the ability to meet deadlines under pressure


Perks & Benefits

  • Competitive salary based on experience

  • Health insurance and wellness support

  • Performance-based incentives and bonuses

  • Exposure to global pharmacovigilance operations

  • Structured learning and career advancement programs

  • Collaborative work environment


Company Description

This opportunity is with a leading pharmaceutical and drug safety service provider with a strong footprint in regulatory affairs and pharmacovigilance across global markets. The company is known for compliance-focused healthcare solutions and delivering high-quality safety data management and reporting services.


Call to Action

Are you ready to accelerate your career in pharmacovigilance leadership?
Apply now for the Manager – Pharmacovigilance role in Delhi and contribute to global drug safety initiatives.

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