Senior Pharmacovigilance Associate
Location: Chennai, India
Work Model: Office with Flex
Employment Type: Full-Time
Company: ICON plc
Experience Required: Minimum 4 years (Case Processing + LSMV skills)
Job ID: JR139662
About ICON plc
ICON plc is a global leader in healthcare intelligence and clinical research. The organization is committed to scientific excellence, innovation, and an inclusive culture where professionals can grow while contributing to advancements in drug development and patient safety.
Role Overview
The Senior Pharmacovigilance Associate will be responsible for overseeing and executing critical pharmacovigilance activities to ensure the safety and regulatory compliance of pharmaceutical products. This role demands expertise in case processing, strong LSMV database skills, and the ability to guide junior team members in PV operations.
Key Responsibilities
Adverse Event Case Management
Lead the end-to-end process for collecting, evaluating, and documenting adverse event reports in accordance with global regulatory requirements.
Ensure high-quality, accurate, and timely reporting into pharmacovigilance systems.
Maintain and manage safety databases, ensuring accuracy and compliance with data management standards.
Safety Data Analysis & Signal Identification
Analyze safety data, interpret clinical relevance, and identify trends that may indicate potential safety concerns.
Collaborate with clinical and medical teams to support risk assessment and safety signal evaluation.
Regulatory Documentation
Prepare and submit periodic safety update reports (PSURs) and other regulatory deliverables following international guidelines.
Maintain complete and compliant documentation across all safety reporting processes.
Team Leadership & Training
Mentor and train junior pharmacovigilance professionals on case processing, regulatory standards, and best practices.
Provide guidance to ensure consistency, quality, and compliance across PV operations.
Audit & Inspection Support
Participate in regulatory audits and inspections, ensuring all documentation and processes are audit-ready.
Maintain robust compliance across all pharmacovigilance activities.
Process Improvement & Compliance
Stay updated with evolving regulatory requirements and industry trends.
Contribute to continuous improvement initiatives and quality enhancement across PV workflows.
Candidate Profile
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline.
Advanced degree preferred.
Experience
Minimum 4+ years of pharmacovigilance case processing experience.
Proven expertise with LSMV database skills.
Strong understanding of global PV regulations and safety reporting requirements.
Skills & Competencies
Strong analytical and critical thinking skills to interpret complex medical data.
Proficiency in PV databases, safety systems, and MS Office tools.
Excellent communication and interpersonal skills.
Ability to work independently in a fast-paced, deadline-driven environment.
High level of integrity and commitment to data confidentiality.
What ICON Offers
ICON provides a competitive compensation package along with comprehensive benefits designed to support well-being, work-life balance, and long-term career growth.
Sample Benefits Include:
Competitive annual leave policies
Health insurance plans tailored to individual and family needs
Retirement benefit offerings
Global Employee Assistance Programme (TELUS Health)
Life assurance
Flexible optional benefits (childcare vouchers, gym discounts, subsidized travel, etc.)
ICON is committed to fostering an inclusive, discrimination-free workplace and provides reasonable accommodations for candidates with medical needs or disabilities.
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