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Senior Pharmacovigilance Associate

4 years
Not Disclosed
10 Dec. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Senior Pharmacovigilance Associate – Chennai (LSMV Database Expertise)

Location: Chennai
Job ID: JR139662
Department: Drug Safety – ICON Full Service & Corporate Support
Employment Type: Office-Based


About the Company

ICON plc is a global leader in healthcare intelligence and clinical research. The organization is committed to advancing clinical development through high-quality data, robust scientific expertise, and a culture that promotes innovation, collaboration, and continuous improvement. ICON partners with leading biopharmaceutical companies worldwide to support drug safety, regulatory compliance, and patient-focused clinical programs.


Role Overview

ICON is seeking a Senior Pharmacovigilance Associate with strong expertise in LSMV database management and advanced case processing. This role is responsible for leading critical pharmacovigilance activities to ensure compliance with global safety regulations and support ongoing clinical development programs.

The position is suited for experienced drug safety professionals who can manage complex safety cases, mentor junior team members, and contribute to high-impact safety operations.


Key Responsibilities

  • Lead and perform end-to-end case processing, ensuring accuracy, completeness, and timely submission of adverse event reports according to global regulatory standards.

  • Utilize strong LSMV database capabilities to ensure data integrity, quality oversight, and system compliance.

  • Conduct in-depth evaluation of safety data, identifying potential trends, safety signals, and risks requiring further assessment.

  • Prepare and support the submission of Periodic Safety Update Reports (PSURs) and other regulatory safety documents.

  • Collaborate with cross-functional medical, clinical, and regulatory teams to assess the clinical relevance of reported adverse events.

  • Maintain exceptional documentation quality and adherence to pharmacovigilance SOPs and ICH guidelines.

  • Participate in internal and external audits, ensuring inspection readiness and compliance with international standards.

  • Mentor and train junior pharmacovigilance staff on processes, regulatory expectations, and best practices.

  • Stay updated on evolving global safety regulations to support continuous process improvement.


Experience Required

  • Minimum 4 years of hands-on pharmacovigilance case processing experience, with demonstrated expertise in LSMV database systems.

  • Strong understanding of global pharmacovigilance regulations, safety reporting workflows, and clinical safety processes.

  • Experience in adverse event evaluation, narrative writing, safety trending, and signal detection.

  • Prior experience supporting audits, inspections, and regulatory submissions preferred.


Education Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.

  • Advanced degrees (MSc, PharmD, MPH) are preferred.


Skills and Competencies

  • Proficiency in pharmacovigilance databases, data management systems, and Microsoft Office tools.

  • Strong analytical thinking with the ability to interpret complex clinical and safety data.

  • Excellent communication and interpersonal skills to collaborate across cross-functional teams.

  • Ability to manage multiple priorities, work independently, and maintain confidentiality of sensitive safety information.

  • High attention to detail and commitment to maintaining data accuracy.


What ICON Offers

ICON provides a competitive and supportive work environment focused on professional development and employee well-being. Benefits may include:

  • Competitive compensation and performance-based incentives

  • Comprehensive health insurance and wellness programs

  • Retirement and long-term financial planning options

  • Generous annual leave and flexible working arrangements

  • Global Employee Assistance Programme (LifeWorks)

  • Country-specific optional benefits such as childcare vouchers, travel subsidies, gym memberships, and health assessments

  • A culture that values inclusion, diversity, accessibility, and equal opportunity


Why Join ICON?

By joining ICON, you contribute to safety initiatives that directly impact global healthcare outcomes. The organization encourages growth, innovation, and excellence, making it an ideal environment for advancing your pharmacovigilance career.