India's DMPLOI - Jobs & Networking AppICON plc is inviting applications for the position of Senior Pharmacovigilance Associate at its Chennai, Tamil Nadu office. This is an excellent opportunity for experienced pharmacovigilance professionals who are passionate about drug safety, clinical research, and regulatory compliance.
If you have hands-on experience in adverse event processing, safety reporting, and pharmacovigilance systems, this opportunity could be the ideal next step in your career.
Job Overview
- Company: ICON plc
- Position: Senior Pharmacovigilance Associate
- Job Location: Chennai, Tamil Nadu, India
- Job Type: Full-Time
- Industry: Clinical Research / Pharmacovigilance / Drug Safety
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization committed to advancing clinical development through innovation, scientific excellence, and patient-focused solutions. The company provides comprehensive clinical, consulting, and commercial services to pharmaceutical, biotechnology, and medical device organizations worldwide.
Key Responsibilities
As a Senior Pharmacovigilance Associate, you will be responsible for:
- Lead the collection, evaluation, and processing of adverse event (AE) and serious adverse event (SAE) reports.
- Ensure timely and accurate safety reporting in accordance with global regulatory requirements.
- Perform SAE/AE case processing for clinical trials.
- Work with Electronic Data Capture (EDC) systems such as RAVE and safety databases like Argus Safety.
- Understand protocol timelines and regulatory reporting requirements.
- Support the preparation of Development Safety Update Reports (DSURs).
- Participate in reconciliation activities between clinical and safety databases.
- Analyze safety data to identify trends and potential safety signals.
- Prepare and submit Periodic Safety Update Reports (PSURs) and other regulatory documents.
- Collaborate with medical and clinical teams for safety assessments and risk management activities.
- Maintain pharmacovigilance databases and ensure data integrity.
- Mentor new team members and review Standard Operating Procedures (SOPs).
- Support regulatory audits and inspections while ensuring pharmacovigilance compliance.
Required Qualifications
Candidates should possess:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or another relevant scientific or healthcare discipline.
- Extensive experience in Pharmacovigilance or Drug Safety.
- Strong understanding of global pharmacovigilance regulations and industry standards.
- Experience in adverse event reporting, case processing, and signal detection.
- Hands-on experience with Argus Safety and EDC systems (RAVE preferred).
- Knowledge of DSUR preparation, reconciliation processes, and regulatory reporting timelines.
- Excellent analytical, communication, and interpersonal skills.
- Proficiency in Microsoft Office applications.
- Ability to work independently while managing multiple priorities.
- Willingness to travel occasionally (approximately 15%).
Preferred Skills
- Clinical trial safety management
- SAE/AE case processing
- Drug safety database management
- Regulatory compliance
- Signal detection and safety analysis
- Risk management
- Team mentoring and training
- Cross-functional collaboration
Employee Benefits
ICON plc offers a competitive compensation package along with a comprehensive range of employee benefits, including:
- Competitive salary package
- Annual leave benefits
- Health insurance for employees and eligible family members
- Retirement planning benefits
- Global Employee Assistance Programme (LifeWorks)
- Life insurance coverage
- Flexible country-specific benefits
- Childcare support (where applicable)
- Discounted gym memberships
- Subsidized travel benefits
- Health assessment programs
- Excellent work-life balance initiatives
- Opportunities for global career growth and professional development
Why Join ICON plc?
Joining ICON means becoming part of one of the world’s leading clinical research organizations where innovation, diversity, and employee development are valued. You’ll work alongside experienced professionals while contributing to global drug safety and improving patient outcomes.
If you’re looking to advance your pharmacovigilance career with a globally recognized CRO, this is an excellent opportunity to explore.
Apply now and take the next step in your pharmacovigilance career with ICON plc.
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