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Senior Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 Sept. 22, 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

Job Title: Senior Pharmacovigilance Reporting Associate

Locations:

  • Chennai, India

  • Trivandrum, India

  • Bangalore, India

Work Type: Office with Flex / Remote
Employment Type: Full-time
Job Requisition ID: JR133444
Posted: 7 days ago


Company Overview – ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence. ICON’s mission is to shape the future of clinical development by providing high-quality solutions and advancing patient outcomes.


Role Overview

As a Senior Pharmacovigilance Reporting Associate, you will play a critical role in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will collaborate with cross-functional teams to enhance pharmacovigilance reporting processes and ensure compliance with regulatory standards.


Key Responsibilities

  • Prepare and submit adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.

  • Collaborate with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals.

  • Assist in preparing periodic safety update reports (PSURs), annual reports, and other regulatory documents.

  • Monitor timelines for safety report submissions and proactively manage delays or issues.

  • Maintain and update pharmacovigilance databases, ensuring data integrity and quality.

  • Train and support junior team members on reporting procedures and regulations.

  • Participate in audits and inspections by regulatory authorities, ensuring compliance with all reporting requirements.

  • Stay informed on changes in regulatory guidelines and industry standards to maintain best practices in pharmacovigilance reporting.


Required Qualifications & Skills

  • Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred)

  • Experience: Extensive experience in pharmacovigilance or drug safety reporting

  • Strong knowledge of regulatory requirements and pharmacovigilance guidelines

  • Proven ability to prepare and submit accurate adverse event reports on time

  • Strong analytical skills to interpret safety data and identify trends

  • Excellent communication and interpersonal skills

  • Proficiency in pharmacovigilance databases, reporting tools, and Microsoft Office Suite

  • Ability to manage multiple projects in a fast-paced environment with attention to detail

  • Commitment to confidentiality and handling sensitive patient information


What ICON Offers

  • Competitive salary with additional benefits focused on well-being and work-life balance

  • Examples of benefits:

    • Various annual leave entitlements

    • Health insurance for you and your family

    • Competitive retirement planning options

    • Global Employee Assistance Programme (24/7 support via TELUS Health)

    • Life assurance

    • Flexible optional benefits: childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments


Diversity & Inclusion

  • ICON is committed to an inclusive and accessible environment.

  • Workplace free from discrimination and harassment.

  • Equal employment consideration for all candidates regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

  • Reasonable accommodations provided for medical conditions or disabilities during application or employment.


Application Note

  • Candidates who do not meet all requirements are still encouraged to apply. ICON values diverse experiences and skills.

  • Current ICON employees should apply via internal channels.