Bio-Clinaarc Pvt. Ltd.
Published on: 18th August 2025
Position: Pharmacovigilance (PV) Associate
Location: Mumbai, Maharashtra
Experience: Minimum 1 year
Qualification: B.Pharm / M.Pharm
Application Type: Email Submission
🌟 Why Choose Careers @ Pharma?
Opportunity to work with a reputed global Contract Research Organization (CRO).
Exposure to pharmacovigilance operations, regulatory compliance, and safety reporting.
Hands-on experience with leading safety databases and global PV regulations.
Career growth in a knowledge-driven and supportive work environment.
🏢 About the Company
Bio-Clinaarc Pvt. Ltd., established in 2015 and headquartered in Nagpur, is a Contract Research Organization (CRO) offering end-to-end solutions in clinical operations, data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs. With expertise across multiple therapeutic areas—including oncology, neurology, cardiology, dermatology, and infectious diseases—Bio-Clinaarc supports global pharmaceutical and biotech companies in their drug development journey. The company is recognized for its compliance-driven approach and diverse team of 50–100 professionals.
📌 Job Specification – PV Associate
Key Responsibilities:
Case Processing:
Collect, review, and process AE/ADR reports from clinical trials and post-marketing sources.
Enter Individual Case Safety Reports (ICSRs) into safety databases.
Safety Data Evaluation:
Assess seriousness, causality, expectedness, and completeness of AE/ADR reports.
Apply accurate MedDRA coding for adverse events.
Regulatory Compliance:
Prepare, track, and submit expedited/periodic safety reports (PSURs, PADERs, DSURs).
Ensure adherence to ICH, GVP, FDA, EMA, and CDSCO guidelines.
Signal Detection & Risk Management:
Identify potential safety trends and support signal detection activities.
Assist in risk-benefit assessments and risk minimization strategies.
Literature Surveillance:
Screen medical literature for safety data related to assigned products.
Capture published case reports and relevant safety findings.
🎯 Candidate Requirements
Education: B.Pharm / M.Pharm
Experience: Minimum 1 year in pharmacovigilance
Skills & Competencies:
PV case processing (ICSRs, SAE/AE handling)
Knowledge of global regulatory frameworks (ICH-GCP, ICH-E2B, EMA GVP, US FDA, CDSCO)
Safety database handling (Argus, ArisG, Veeva Vault Safety, etc.)
MedDRA & WHO Drug coding proficiency
Experience with PSUR / PADER / DSUR submissions
Literature search & adverse event identification
Basics of signal detection and risk management
📍 Location
Mumbai, Maharashtra
📑 Hiring Process
Mode of Application: Email-based
Interested candidates should send their updated CV to:
📧 hr@clinaarc.com
Subject line: PV Associate – Mumbai