ICON plc Hiring for Senior Pharmacovigilance Reporting Associate (Chennai/Bangalore/Trivandrum). Must have ICSR submission experience. Apply now!
Job Requisition ID: JR134474
Location: Chennai | Bangalore | Trivandrum (India) – Office with Flex (hybrid model)
Employment Type: Full Time
Application Status: Open – Posted Today | High demand role – early application strongly recommended
Key Highlights
- World-leading CRO ICON plc – trusted partner to top 20 pharma and emerging biotech
- Critical role focused on regulatory submission of ICSRs (E2B R3) to global health authorities
- Direct responsibility for on-time, high-quality safety report submissions (FDA, EMA, MHRA, PMDA, Health Canada, etc.)
- Excellent visibility with Global Safety, Regulatory Affairs, and Client teams
- Strong career progression path: Senior Associate → Lead → Manager → Associate Director (Reporting & Submissions)
- Highly flexible “Office with Flex” policy + best-in-class benefits package
- Multiple locations across South India – choose Chennai, Bangalore, or Trivandrum
ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
The Role – What You Will Own
As a Senior Pharmacovigilance Reporting Associate with proven safety report submission experience, you will be the final gatekeeper ensuring every Individual Case Safety Report (ICSR) and aggregate report leaves ICON compliant, complete, and on time. This is not a case-processing role — this is a regulatory submission specialist position requiring precision, regulatory intelligence, and deadline mastery. ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
Day-to-Day Responsibilities
- Prepare, validate, and electronically submit ICSRs (E2B R3 XML) via global gateways (EVWEB, EudraVigilance, FDA ESG, PMDA gateway, etc.)
- Manage submission timelines for 24-hour, 48-hour, 7-day, and 15-day expedited reports
- Perform pre- and post-submission quality review and acknowledgment reconciliation
- Lead preparation and submission of aggregate reports including DSURs, PADERs, PBRERs/PSURs, and RMPs
- Act as primary point of contact for health authority queries on submitted cases
- Maintain 100% compliance with client-specific distribution rules and global regulatory timelines
- Drive root-cause analysis and CAPA for any late or rejected submissions
- Mentor junior associates on submission best practices and gateway troubleshooting
- Represent Pharmacovigilance in client audits and regulatory inspections
- Stay ahead of evolving global submission requirements (EudraVigilance re-certification, ISO IDMP, FAERS updates, etc.)
ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
Essential Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, Medicine, or related field (advanced degree preferred)
- Minimum 4–7 years of hands-on pharmacovigilance experience with at least 3 years in ICSR regulatory submission/electronic reporting
- Proven track record of successful E2B R3 submissions to EMA, FDA, MHRA, Health Canada, PMDA, and other major agencies
- Expert user of at least one global safety database with submission module (ARGUS, ARISg, or Oracle Argus preferred)
- In-depth knowledge of ICH-GCP, GVP Module VI, FDA post-marketing requirements, and EU/UK reporting rules
- Experience with gateway management (EVWEB, ESG WebTrader, CESP, PMDA gateway) and acknowledgment reconciliation
- Strong English medical writing and regulatory communication skills
- Ability to manage high-volume submission workload without compromising quality
ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
Highly Desirable Skills (Will Make You Stand Out)
- Prior experience in a CRO environment managing multiple sponsor requirements simultaneously
- Hands-on experience with aggregate report authoring (PSUR/PBRER, DSUR)
- Certification in pharmacovigilance or regulatory affairs
- Familiarity with signal detection support or literature review workflows
- Experience supporting health authority inspections or client audits
Why Join ICON Pharmacovigilance India
ICON is one of the largest and most respected global CROs with an outstanding reputation in drug safety. Our India Safety teams in Chennai, Bangalore, and Trivandrum are strategic hubs delivering 24/7 coverage for global clients. ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
You will benefit from: ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
- Competitive salary + annual performance bonus
- Hybrid “Office with Flex” model (typically 2–3 days in office)
- Comprehensive health insurance for self + family
- 24/7 TELUS Health Employee Assistance Programme
- Life assurance and retirement planning support
- Generous annual leave + public holidays
- Structured training budget and clear promotion framework
- Exposure to cutting-edge molecules in oncology, rare diseases, cell & gene therapy, and vaccines
How to Apply – Step by Step (Act Fast)
Applications are accepted exclusively through the official ICON careers portal.
- Visit the direct job link: https://careers.iconplc.com/job/JR134474
(Or search requisition JR134474 on https://careers.iconplc.com) - Click “Apply for this job online”
- Register or log in to your ICON candidate account
- Upload your updated CV (PDF or Word) clearly highlighting your submission experience and number of ICSRs handled
- Complete the application form and screening questions
- Submit your application today — this role is moving quickly
Current ICON employees: use the internal careers portal link provided in the original posting. ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
Final Note from ICON
If you live and breathe regulatory timelines, love the satisfaction of a perfectly submitted ICSR, and want to be part of a world-class safety team that delivers for the biggest names in pharma — this is your role. ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
Don’t wait. Applications are being reviewed in real time, and the position may close earlier than advertised once the right candidates are identified.
Join ICON. Shape the future of clinical development — one submission at a time. ICON plc Hiring for Senior Pharmacovigilance Reporting Associate
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
