Senior Pharmacovigilance Associate

ICON plc

Senior Pharmacovigilance Associate ensuring safety and efficacy of drugs at ICON. Leading pharmacovigilance activities and managing reports in a global healthcare organization.

Posted 7/10/2026full-timeChennai • 🇮🇳 IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and drug safety, with a strong focus on adverse event reporting, data analysis, and regulatory compliance. Capable of mentoring team members and leading cross-functional collaborations to ensure effective risk management and adherence to industry standards.

Highest-signal resume keywords

Pharmacovigilance Process ManagementAdverse Event ReportingData Analysis and InterpretationRegulatory ComplianceMentorship and Training

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceAdverse Event ProcessingData AnalysisSignal DetectionRegulatory ReportingProtocol UnderstandingSafety Data InterpretationDatabase ManagementSOP ReviewDSUR Preparation

Soft Skills

Analytical ThinkingCommunication SkillsInterpersonal SkillsCollaborationIndependent Work

Tools & Technologies

EDC SystemsRAVEArgus SafetyMicrosoft Office Suite

Industry Keywords

Pharmacovigilance GuidelinesDrug SafetyClinical TrialsSafety Update ReportsRegulatory AuthoritiesCompliance Standards

About the role

Key responsibilities & impact

Take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges
Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies
Experience in SAE/AE processing for clinical trials
Familiarity with EDC systems (e.g., RAVE) and Argus Safety
Understanding of protocol timelines and regulatory reporting
Support DSUR preparation
Ability to mentor new joiners and review SOPs
Familiarity with reconciliation processes
Conduct thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation
Prepare and submit comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations
Collaborate with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities
Oversee the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards
Provide training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices
Engage in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements

Requirements

What you’ll need

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection
Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations
Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite
Ability to work independently and manage multiple priorities in a fast-paced environment
Willingness to travel as required (approximately 15%)

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways