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.
Explore more such roles at ThePharmaDaily.com
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