Pharmacovigilance Analyst

Auriga Research; Gurugram District; On-site; INR 600,000 - 900,000; Full time

Job summary

Auriga Research is seeking a Pharmacovigilance professional to process ICSR submissions for client products, including non-standard adverse event terminology, and to support ongoing PV activities.

The ideal candidate has 3–4 years of PV experience in a CRO, pharmaceutical company, or PV service provider, with working knowledge of ICSR processing, MedDRA coding, and regulatory PV timelines, and an understanding of PvPI.

Qualifications

• Minimum 3-4 years of PV experience in a CRO, pharmaceutical company, or PV service provider
• Working knowledge of ICSR processing, MedDRA coding, and regulatory PV reporting timelines
• Understanding of Indian pharmacovigilance regulatory framework (PvPI)

Responsibilities

• Process Individual Case Safety Reports (ICSRs) for client products, including non-standard adverse event terminology
• Support PVPI reporting requirements for assigned clients
• Conduct literature monitoring for product safety signals across assigned therapeutic areas
• Support Periodic Safety Update Report (PSUR) preparation and submission for clients
• Maintain PV case processing timelines in line with regulatory reporting obligations
• Support signal detection and evaluation activities using standard methodologies
• Liaise with clients on PV retainer scope, reporting cadence, and query resolution

Skills

PV experience

ICSR processing

MedDRA coding

Regulatory PV

Education

B.Pharm / M.Pharm / Pharm.D

Job description

Role & responsibilities

Process Individual Case Safety Reports (ICSRs) for client products, including non-standard adverse

event terminology

• Support PVPI (Pharmacovigilance Programme of India) reporting requirements for assigned clients
• Conduct literature monitoring for product safety signals across assigned therapeutic areas
• Support Periodic Safety Update Report (PSUR) preparation and submission for clients
• Maintain PV case processing timelines in line with regulatory reporting obligations
• Support signal detection and evaluation activities using standard methodologies
• Liaise with clients on PV retainer scope, reporting cadence, and query resolution

Preferred candidate profile

B.Pharm / M.Pharm / Pharm.D with dedicated pharmacovigilance experience

• Minimum 3-4 years of PV experience in a CRO, pharmaceutical company, or PV service provider
• Working knowledge of ICSR processing, MedDRA coding, and regulatory PV reporting timelines
• Understanding of Indian pharmacovigilance regulatory framework (PvPI)