A new opportunity is available for PV Scientist – Case Processing professionals in Mumbai and Noida. This pharmacovigilance role focuses on end-to-end ICSR case processing within a high-volume OTC and consumer healthcare drug safety program.

The PV Scientist will work across the complete safety case lifecycle, including case intake, triage, validity assessment, data entry, MedDRA coding, narrative writing, follow-up and E2B submission. The position is particularly relevant for candidates building their careers in pharmacovigilance, drug safety and ICSR case management.

Structured training is expected to support the development of case processing competency and program-specific knowledge.

Key Job Details

Key Responsibilities

As a PV Scientist – Case Processing, the selected candidate may be responsible for:

• Performing safety case intake and case book-in activities.
• Conducting ICSR triage and initial validity assessment according to applicable SOPs.
• Performing accurate pharmacovigilance safety database data entry.
• Coding adverse events, medical history and other relevant information using MedDRA.
• Preparing clear and medically coherent ICSR case narratives.
• Managing case follow-up activities and documenting additional information received.
• Supporting E2B safety case submissions within applicable timelines.
• Maintaining accuracy, quality and regulatory compliance throughout the case lifecycle.
• Identifying and escalating potentially serious, complex or unusual safety cases.
• Following program-specific SOPs, work instructions and quality requirements.
• Participating in pharmacovigilance training and competency-development activities.
• Supporting high-volume consumer healthcare and OTC case processing operations.

Qualification & Eligibility

Candidates with a relevant healthcare or life sciences background may be considered. Preferred qualifications include:

B.Pharm / M.Pharm / Pharm.D / BHMS / BDS or equivalent relevant healthcare, pharmacy or life sciences qualification.

The role description indicates that candidates should preferably have exposure to pharmacovigilance, drug safety, clinical safety or another related scientific/clinical domain. Candidates should assess their individual eligibility against the employer’s final screening requirements before applying.

Skills Required for PV Scientist Case Processing

Candidates interested in this pharmacovigilance job should have knowledge or exposure to:

• ICSR case processing
• Case intake and book-in
• Case triage
• Validity assessment
• Pharmacovigilance data entry
• MedDRA coding
• Narrative writing
• Case follow-up
• E2B submissions
• Drug safety databases
• Oracle Argus Safety
• LSMV
• Veeva Safety or equivalent PV databases
• Quality and compliance
• Pharmacovigilance SOPs
• Consumer healthcare pharmacovigilance
• OTC safety case processing

Knowledge of the end-to-end ICSR lifecycle will be particularly useful for this position.

What Does a PV Scientist – Case Processing Do?

A PV Scientist working in case processing helps convert adverse-event information received from patients, healthcare professionals, consumers and other sources into structured Individual Case Safety Reports (ICSRs).

The professional reviews the information to determine whether a valid safety case exists, enters relevant data into the safety database, applies appropriate medical terminology coding, prepares the case narrative, conducts follow-up where required and supports regulatory submission.

In an OTC or consumer healthcare pharmacovigilance program, the volume of reports can be high and many cases may be non-serious. Therefore, accuracy, productivity, medical understanding and compliance with processing timelines are important.

Why Consider This Pharmacovigilance Role?

This opportunity can provide practical exposure to several core pharmacovigilance activities rather than focusing on only one stage of case processing.

Potential professional-development benefits include:

• Exposure to the complete ICSR lifecycle.
• Practical experience with MedDRA coding and narrative writing.
• Experience handling consumer healthcare and OTC safety cases.
• Exposure to pharmacovigilance safety databases.
• Understanding of E2B safety reporting workflows.
• Structured training and development.
• Opportunity to strengthen drug safety quality and compliance knowledge.
• Career progression potential within pharmacovigilance operations.

Experience in end-to-end case processing can also provide a foundation for future opportunities in quality review, aggregate reporting, signal management, safety surveillance and pharmacovigilance operations.

How to Apply

Application Link