company-details

Pharmacovigilance Associate

Clinical Research

22 hours ago

Agar, Bagh, Banda, Barghat, Basoda

₹ 20K - 50K
Batch Processing
GMP
HPLC
Inventory
Lab
Management
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
  • Computer Skill
  • Leadership Skill
  • GMP
  • Compliance
  • Formulation
  • Design
Job Overview

Date Posted:

27th Feb, 2026

Expiration date:

1st Apr, 2026

Location:

Madhya Pradesh, India

Job Type:

Full-Time

Functional Areas:

PV/Drug Safety

Positions:

26

Job Experience:

2 Year

Company Overview
company-details

NovaCure Pharmaceuticals Pvt. Ltd.

View company profile

Founded in:

2022

Phone:

7898447653

Location:

76th Floor, Orion Tech Park HITEC City, Madhapur Hyderabad, TelangaUnit 302, Prestige Omega EPIP Zone, Whitefield Bengaluru, Karnataka – 560066 Indiana – 500081 India

Open Jobs : 5
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