Pharmacovigilance Associate

Clinical Research

1 week ago

Ambikapur, Amguri, Anand Nagar, Barpeta Road, Bihpuria

₹ 20K - 30K

Clinical

HPLC

Lab

Management

Manufacturing

Microbiology

Job Description

Detail-oriented Pharmacovigilance Associate with experience in case processing, adverse event reporting, and regulatory compliance. Hands-on exposure to Individual Case Safety Reports (ICSR), MedDRA coding, narrative writing, and safety database management. Strong understanding of global regulatory guidelines including USFDA, EMA, and ICH standards.

Key Responsibilities

1️⃣ Case Processing & Data EntryReviewed and processed Individual Case Safety Reports (ICSRs) from multiple sources (clinical trials, spontaneous reports, literature).Performed data entry in safety databases (e.g., Argus / ArisG).Ensured completeness and accuracy of case information.2️⃣ Medical CodingCoded adverse events, indications, and medications using MedDRA and WHO-Drug dictionary.Ensured correct Preferred Terms (PT) and System Organ Class (SOC) selection.3️⃣ Narrative WritingPrepared medically accurate case narratives.Ensured chronological description of events with clarity and regulatory compliance.4️⃣ Regulatory ComplianceFollowed ICH E2B guidelines for expedited reporting.Maintained compliance with global regulatory timelines (7-day / 15-day reporting).Performed quality checks before submission.5️⃣ Literature ScreeningReviewed scientific journals and medical literature to identify safety-related information.Extracted relevant adverse event data.6️⃣ Follow-up ActivitiesRequested follow-up information from reporters.Updated cases based on additional clinical data.

Skill & Experience

Communication Skill
Customer service Skill
Interpersonal Skill
Leadership Skill
Compliance

Job Overview

Date Posted:

16th Feb, 2026

Expiration date:

31st Mar, 2026

Location:

Assam, India

Job Type:

Full-Time

Functional Areas:

Clinical Research

Positions:

Job Experience:

12 Year

Company Overview

NovaCure Pharmaceuticals Pvt. Ltd.

View company profile

Founded in:

2011

Phone:

7848783732

Location:

indore

Open Jobs : 4

Pharmacovigilance Associate

Job Description

Key Responsibilities

Skill & Experience

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