Pharmazone is hiring freshers for an ICSR – Pharmacovigilance role in Ahmedabad. This is a full-time, permanent, on-site opportunity for candidates with a BDS, M.Pharm, or PharmD qualification who want to begin their career in pharmacovigilance and drug safety.

The role focuses on Individual Case Safety Report (ICSR) processing, adverse event assessment, safety data review, medical coding, case narratives, quality review, and regulatory reporting. Candidates should have a good understanding of adverse events and pharmacovigilance concepts along with strong English communication skills.

Pharmazone ICSR Pharmacovigilance Job Details

About the ICSR Pharmacovigilance Role

The Pharmazone Pharmacovigilance opportunity is designed for freshers who are genuinely interested in building a career in drug safety and pharmacovigilance.

Selected candidates will work on end-to-end ICSR case processing, including reviewing incoming safety information, evaluating adverse events, identifying duplicate or invalid cases, performing medical coding, preparing case narratives, responding to queries, and completing cases within applicable regulatory and service-level timelines.

The position can provide exposure to different types of safety cases, including spontaneous reports, clinical trial cases, literature cases, market research cases, social media cases, and solicited reports.

Key Responsibilities

Candidates selected for the Pharmazone ICSR Pharmacovigilance position may be responsible for:

• Analysing, reviewing, and interpreting safety information from clinical and non-clinical sources, literature, and other relevant sources.
• Performing end-to-end Individual Case Safety Report (ICSR) processing within applicable regulatory timelines.
• Conducting initial evaluation of spontaneously reported adverse events, including reports from post-marketing surveillance activities.
• Identifying duplicate and invalid ICSRs.
• Processing serious and non-serious cases from clinical trials, literature, spontaneous reports, market research, social media, and solicited sources.
• Performing required data entry into EDC databases.
• Conducting peer review and quality review of safety cases when required.
• Performing quality checks on EDC data entered into the system.
• Raising queries when additional information or clarification is required.
• Performing accurate and consistent coding of events, drugs, procedures, indications, and laboratory tests using applicable dictionaries such as MedDRA, WHO-DD, and company product dictionaries.
• Preparing accurate and complete case narratives containing relevant safety information.
• Ensuring cases are processed accurately and submitted within applicable timelines and service-level agreements.
• Supporting pharmacovigilance and drug safety training programs.
• Collaborating with Regulatory Affairs teams regarding appropriate reporting of pharmacovigilance and drug safety information.
• Supporting vendor-related pharmacovigilance and drug safety activities.
• Contributing to training and mentoring of Pharmacovigilance Associates as applicable.

Eligibility and Qualifications

Applicants should meet the following requirements:

• BDS
• M.Pharm
• PharmD
• Freshers interested in starting a career in Pharmacovigilance / Drug Safety
• Understanding of ICSRs and adverse events
• Knowledge of Adverse Events (AE) and Adverse Drug Reactions (ADR)
• Basic understanding of serious adverse event reporting
• Strong written and verbal English communication skills
• Willingness to work in an on-site role in Ahmedabad

Candidates should carefully review the requirements before applying and should apply only if they are genuinely interested in pursuing a career in pharmacovigilance.

Key Skills Required

Important skills and knowledge areas for this position include:

ICSR Case Processing, Pharmacovigilance, Adverse Events, ADR, Serious Adverse Event Reporting, Drug Safety, MedDRA, WHO-DD, Case Narrative Writing, Medical Coding, Safety Data Review, Quality Review, and Regulatory Reporting.

What Freshers Can Learn in This Role

An entry-level ICSR Pharmacovigilance position can provide practical exposure to several important areas of drug safety, including:

• Individual Case Safety Report processing
• Adverse event assessment
• Seriousness assessment
• Duplicate and validity checks
• Medical terminology and coding
• MedDRA coding
• Drug and indication coding
• Safety narrative preparation
• Quality review
• Regulatory reporting timelines
• Clinical trial and post-marketing safety information
• Literature and social-media safety cases
• Pharmacovigilance documentation and compliance

This makes the role relevant for pharmacy and healthcare graduates looking to establish a career in pharmacovigilance, clinical safety, drug safety operations, and related life-sciences functions.

Salary and Job Location

The listed compensation for the Pharmazone ICSR Pharmacovigilance position is ₹2,00,000 per year.

The position is based in Ahmedabad, Gujarat, and the job is described as full-time, permanent, and on-site.

How to Apply for Pharmazone ICSR Pharmacovigilance Job

Interested and eligible candidates can apply by sending their updated CV/resume to:

hr@pharmazones.com