PHARMAFull-time
Pharmacovigilance Associate
By Admin · Pharmacovigilance & Drug Safety
CHENNAI (IN)HYBRIDPOSTED: 8/31/2026
PHARMAFull-time
HIRING ORGANIZATIONICON PLCTechnology
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Perform end-to-end Individual Case Safety Report (ICSR) processing including intake, triage, data entry, narrative writing, coding, and case finalization.
Collect, assess, and process adverse event (AE) reports ensuring accuracy and regulatory compliance.
Manage safety inbox, acknowledge receipt, and perform case book-in activities.
Code adverse events, drugs, and medical history using MedDRA and WHO-DD dictionaries.
Conduct quality control (QC) checks and ensure adherence to global pharmacovigilance standards.
Apply seriousness, expectedness, and causality assessments in line with regulatory frameworks.
Generate queries for follow-up information and ensure complete case documentation.
Support reconciliation processes and aggregate reporting activities (PSUR, DSUR).
Technical & Domain Standards
Strong understanding of global pharmacovigilance regulations and reporting requirements.
Knowledge of post-marketing surveillance and clinical trial safety processes.
Familiarity with safety databases and case lifecycle management.
Understanding of Safety Data Exchange Agreements (SDEA), KPIs, and SLAs.
Cross-Functional Collaboration
Collaborate with clinical, regulatory, and safety teams to resolve safety issues.
Support ongoing safety investigations and regulatory submissions.
Assist in SOP reviews and contribute to process improvements.
Quality & Compliance
Ensure all safety cases meet global regulatory timelines and compliance standards.
Maintain high data integrity and documentation accuracy.
Participate in audits and quality assurance processes.
Business Impact
Direct contribution to patient safety through monitoring adverse drug reactions.
Supports global drug development and post-marketing risk management strategies.
Benefits & Total Rewards
Opportunity to work in a global CRO environment.
Exposure to international pharmacovigilance systems and regulatory frameworks.
Structured career growth and training programs.
Collaborative and compliance-driven work culture.
REQUIRED VERIFIED SKILLS
ICSR processing
Adverse Event reporting
MedDRA coding
WHO-DD coding
Pharmacovigilance regulations
Clinical trial safety
Case processing
Narrative writing
Safety database management
QC review
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Entry-level pharmacovigilance roles in India typically range between ₹3.5–6 LPA depending on company type (CRO vs pharma), skillset (ICSR, MedDRA), and productivity metrics. Global CROs like ICON often offer structured increments, performance bonuses, and exposure to international projects, which significantly accelerates earning potential within 2–3 years.
ORGANIZATION CONTEXT & CULTURE
ICON plc is actively hiring for this position.
INDUSTRY: Technology
EXPECTED CAREER ROADMAP
This role is a foundational entry point into pharmacovigilance. Professionals typically progress from Pharmacovigilance Associate to Senior Associate within 2–3 years, followed by roles such as Case Reviewer, Aggregate Report Writer, or Signal Detection Specialist. Long-term pathways include Pharmacovigilance Manager, Drug Safety Lead, and Global Safety Head roles. The domain offers strong global mobility across CROs, pharma companies, and regulatory agencies, with specialization opportunities in risk management, signal detection, and regulatory strategy.
APPLICATION ADVISORY
To stand out, candidates must demonstrate hands-on knowledge of ICSR lifecycle, MedDRA coding, and regulatory timelines (FDA, EMA). Certifications in pharmacovigilance or clinical research add strong credibility. Highlight case processing simulations, internships, or training projects in your resume. During interviews, expect scenario-based questions on causality assessment, case triage, and data accuracy. Speed + accuracy mindset is critical.
RECOMMENDED TRAINING
1/5
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