Pharmacovigilance Services New Associate
Location: Chennai, India
Job Type: Full-Time
Experience Required: 0–1 Year (Freshers and Early Career Professionals)
Job ID: AIOC-S01621308
Job Overview
We are hiring a Pharmacovigilance Services New Associate to support end-to-end drug safety and pharmacovigilance operations for global pharmaceutical clients. This role is ideal for fresh graduates or early-career professionals seeking to build a long-term career in pharmacovigilance, drug safety surveillance, and regulatory compliance.
The position involves intake, triage, processing, and submission of adverse event reports in compliance with global regulatory standards and client-specific SOPs.
Key Responsibilities
Case Intake & Processing
Identify, triage, and create Individual Case Safety Reports (ICSRs) from multiple intake sources including client mailboxes, electronic gateways, and workflow tools
Retrieve and review new safety information and follow-up correspondence for existing cases
Perform end-to-end case processing for serious and non-serious adverse events, including AEs, SAEs, and SUSARs
Data Entry & Medical Coding
Enter accurate case data into the global safety database as per client SOPs and regulatory timelines
Perform medical coding and drug coding using standard dictionaries such as MedDRA and WHO-Drug (WHODD)
Draft clear, compliant case narratives and sender comments (E2B fields)
Regulatory Compliance & Submissions
Ensure timely case submissions in accordance with global regulatory requirements and client SLAs
Monitor submission status, troubleshoot issues, and support reconciliation activities
Support unblinding activities (paper or electronic) when required, as per SOPs
Quality, Follow-up & Documentation
Validate data consistency and resolve discrepancies
Identify missing or unclear safety information and initiate follow-up with reporters or marketing companies
Track pending action items and ensure timely closure
Support audits, inspections, and ad-hoc pharmacovigilance projects
Assist with documentation, archiving, and preparation of meeting agendas and minutes
Required Qualifications
Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related discipline
0–1 year of experience in pharmacovigilance, drug safety, or clinical research (freshers welcome)
Basic understanding of pharmacovigilance processes and adverse event reporting
Familiarity with MedDRA and WHO-Drug dictionaries (preferred)
Working knowledge of MS Word, Excel, and safety databases
Strong English language proficiency (reading, writing, listening, and speaking)
Good medical writing and documentation skills
Key Skills & Competencies
Ability to learn quickly and adapt to regulatory-driven environments
Strong attention to detail and quality-focused mindset
Effective communication and collaboration skills
Ability to work under timelines while meeting quality and compliance standards
Commitment to data confidentiality, patient safety, and regulatory compliance
Why Join This Role?
Entry-level opportunity to build a career in Pharmacovigilance and Drug Safety
Exposure to global safety databases, regulatory reporting, and compliance standards
Structured training and hands-on experience with real-world safety cases
Long-term career pathways in pharmacovigilance operations, case management, and regulatory affairs
SEO & GEO Keywords
Pharmacovigilance Jobs Chennai, Drug Safety Associate India, Entry Level Pharmacovigilance Jobs, ICSR Processing Jobs, MedDRA WHO Drug Coding Careers, Pharmacovigilance Freshers Jobs India.
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