Manager – Pharmacovigilance
Location: Delhi, India
Experience: 5–6 years
Job Type: Full-time
Job Summary
We are seeking an experienced Pharmacovigilance Manager to lead end-to-end drug safety operations, ensure regulatory compliance, and manage case processing activities. Based in Delhi, this mid-senior level role is ideal for PV professionals with a strong background in ICSR processing, safety database management, and regulatory submissions. The ideal candidate will bring leadership, compliance knowledge, and operational expertise to a high-performing global pharmacovigilance team.
Key Responsibilities
Lead and supervise pharmacovigilance activities including case intake, triage, processing, and quality review
Oversee the timely submission of ICSRs to global regulatory authorities (e.g., EMA, FDA)
Ensure compliance with global PV regulations (ICH-GCP, GVP, MedDRA coding)
Maintain and manage safety databases (e.g., Argus, ARISg)
Manage a team of safety associates, providing training and oversight
Collaborate with cross-functional teams including regulatory, clinical, and medical writing
Prepare and support audits, inspections, and CAPA implementation
Review SOPs and contribute to process improvement initiatives
Generate periodic safety reports such as PADERs, DSURs, and PSURs
Required Skills & Qualifications
Bachelor's or Master’s degree in Life Sciences, Pharmacy, or Medicine
5–6 years of experience in pharmacovigilance, including team leadership
Strong understanding of GVP, ICH guidelines, and global safety regulations
Expertise in MedDRA coding, WHO-DD, and PV systems such as Argus or ARISg
Excellent communication, documentation, and compliance monitoring skills
Experience in handling PV audits and regulatory inspections preferred
Ability to multitask, prioritize, and meet strict deadlines
Perks & Benefits
Competitive salary commensurate with experience
Opportunity to lead high-impact pharmacovigilance projects
Access to global drug safety best practices and tools
Health insurance and wellness benefits
Training and continuous professional development
Fast-track career progression in PV leadership
Company Description
Join a top-tier pharmaceutical and healthcare organization committed to advancing drug safety, regulatory excellence, and patient-centric pharmacovigilance. With a strong presence in India and international markets, our team works at the intersection of clinical science and regulatory compliance.
Work Mode: On-site – Delhi
Call-to-Action
Are you ready to take the next step in your pharmacovigilance career?
Apply now to become our next Pharmacovigilance Manager in Delhi and help ensure the safety of patients worldwide.
Visit ThePharmaDaily.com for more opportunities in drug safety and healthcare.
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