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Pharmacovigilance Services New Associate

Accenture
Accenture
0-1 years
preferred by company
10 Jan. 6, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.