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Pharmacovigilance Project Lead

0-2 years
Not Disclosed
10 Oct. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Pharmacovigilance Project Lead – ICON plc

Locations: Bangalore / Chennai / Bengaluru
Job ID: JR136836
Portfolio: Pharmacovigilance & Patient Safety – Full Service & Corporate Support
Work Type: Office-Based


Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, advancing the future of clinical development.


Role Overview

The Pharmacovigilance Project Lead will oversee strategic management of safety monitoring and reporting for clinical trials and post-marketing activities. This role ensures regulatory compliance, leads pharmacovigilance projects, and drives initiatives to enhance patient safety and data integrity across all projects.


Key Responsibilities

  • Lead and manage pharmacovigilance projects, including oversight of safety data collection, evaluation, and reporting.

  • Develop and implement strategies for effective management of adverse event reports and regulatory compliance.

  • Coordinate with cross-functional teams (clinical operations, regulatory affairs, data management) to support project objectives and resolve safety-related issues.

  • Ensure timely preparation and submission of safety reports, including periodic safety updates and risk assessments, to regulatory authorities and sponsors.

  • Provide leadership, guidance, training, and mentoring to pharmacovigilance teams to support project success and compliance.


Required Education & Skills

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degree or certification in pharmacovigilance is a plus).

  • Proven experience in pharmacovigilance or drug safety, with strong knowledge of safety reporting and regulatory requirements.

  • Strong leadership and project management skills, with experience managing complex pharmacovigilance projects and cross-functional teams.

  • Excellent analytical and problem-solving abilities, with a track record of improving safety monitoring processes.

  • Effective communication and interpersonal skills; ability to collaborate with diverse stakeholders and manage multiple priorities in a fast-paced environment.


Benefits

ICON offers competitive compensation along with benefits focused on well-being and work-life balance, including:

  • Annual leave entitlements

  • Health insurance options for employees and families

  • Competitive retirement planning offerings

  • Global Employee Assistance Programme (LifeWorks, 24/7 access to specialized professionals)

  • Life assurance

  • Flexible, country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, health assessments, etc.)

More details: ICON Careers Benefits


Diversity & Inclusion

ICON values inclusion and belonging. All candidates receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Reasonable accommodations are available: Request here


Application Encouragement

Even if you don’t meet all requirements, you are encouraged to apply – you may be exactly what ICON is looking for.