ICON PLC Hiring Pharmacovigilance Associate
- ICON Hiring Pharmacovigilance Associate – 2+ Years Post-Marketing Case Processing | Chennai Hybrid Role
- Company Overview
- Job Role & Responsibilities
- Core Responsibilities
- Post-Marketing & Compliance Activities
- Collaboration & Quality
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Skills Required
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- 1. What experience is required for this role?
- 2. What qualifications are required?
- 3. What are the main responsibilities?
- 4. Is this a good pharma career option?
- 5. What skills are important for selection?
- Summary Table
ICON Hiring Pharmacovigilance Associate – 2+ Years Post-Marketing Case Processing | Chennai Hybrid Role
ICON plc is hiring Pharmacovigilance Associate professionals for its Drug Safety (Post-Marketing) team in Chennai. This is a full-time hybrid opportunity for candidates with at least 2 years of hands-on experience in pharmacovigilance case processing, especially post-marketing surveillance (PMS). The role focuses on ICSR processing, safety database management, MedDRA coding, and global regulatory compliance, making it a strong career move for professionals in drug safety and clinical research.
Company Overview
ICON plc is a global healthcare intelligence and clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to accelerate clinical development and improve patient outcomes. With a strong global footprint and deep expertise in pharmacovigilance, clinical operations, and regulatory services, ICON supports the safe development and monitoring of medicines worldwide.
The company is known for its quality-driven culture, robust safety processes, and commitment to regulatory excellence. Working at ICON provides exposure to global safety databases, international guidelines, and large-scale post-marketing surveillance programs.
Job Role & Responsibilities
As a Pharmacovigilance Associate, you will be responsible for end-to-end case processing of post-marketing adverse events, ensuring timely and accurate reporting in line with global pharmacovigilance regulations.
Core Responsibilities
- Collect, assess, and process adverse event (AE) reports with accuracy and within regulatory timelines
- Perform case triage, book-in, and data entry into safety databases
- Write clear and medically coherent case narratives
- Code events, drugs, and medical history using MedDRA and WHO-DD dictionaries
- Apply correct product labeling and perform quality control (QC) checks
- Finalize case processing and generate follow-up queries as needed
Post-Marketing & Compliance Activities
- Manage safety inbox and acknowledge case receipts
- Ensure correct assessment of seriousness, expectedness, and causality
- Support reconciliation activities and aggregate reporting (PSUR/DSUR)
- Process literature ICSRs and ensure compliance with monitoring requirements
- Maintain adherence to SOPs, SDEA, KPIs, and SLAs
Collaboration & Quality
- Partner with cross-functional teams to resolve safety queries and support investigations
- Mentor junior team members and support SOP reviews when required
- Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines
- Ensure high standards of data quality, compliance, and audit readiness
Eligibility / Qualifications
Educational Qualification
Candidates must have a degree in healthcare or life sciences disciplines.
Required courses include:
B.Pharm, M.Pharm, Pharm.D, BDS, B.Sc Nursing, M.Sc Nursing, BAMS, BHMS
Experience
- Minimum 2 years of experience in pharmacovigilance case processing
- Strong experience in post-marketing surveillance (PMS) case processing
Skills Required
- Strong knowledge of ICSR processing and safety database workflows
- Proficiency in MedDRA and WHO-DD coding
- Understanding of global PV regulations and reporting timelines
- Strong analytical skills and attention to detail
- Excellent communication and documentation skills
- Ability to manage multiple cases and meet deadlines
Location & Salary
- Job Location: Chennai, India
- Work Mode: Hybrid
- Employment Type: Full-time
- Salary: Competitive salary with benefits aligned to pharmacovigilance industry standards
Application Process
Interested candidates can apply through the official ICON careers portal:
Apply Here: https://careers.iconplc.com/job/pharmacovigilance-associate-in-india-chennai-jid-46820
Frequently Asked Questions (FAQs)
1. What experience is required for this role?
Candidates must have at least 2 years of experience in pharmacovigilance, specifically in post-marketing case processing.
2. What qualifications are required?
A degree in Pharmacy, Life Sciences, Nursing, Dental, or AYUSH disciplines is required.
3. What are the main responsibilities?
The role involves ICSR processing, MedDRA coding, narrative writing, and regulatory compliance activities.
4. Is this a good pharma career option?
Yes. Pharmacovigilance is a high-demand field with strong career growth in drug safety and clinical research.
5. What skills are important for selection?
Attention to detail, regulatory knowledge, coding skills, and strong communication abilities.
Summary Table
| Category | Details |
|---|---|
| Company | ICON plc |
| Vacancies | Pharmacovigilance Associate |
| Required Education | B.Pharm, M.Pharm, Pharm.D, BDS, B.Sc Nursing, M.Sc Nursing, BAMS, BHMS |
| Experience | 2+ Years Post-Marketing PV Case Processing |
To apply for this job please visit icon.wd3.myworkdayjobs.com.
