Pharmacovigilance Associate at ICON plc

Chennai, tamil nadu, India -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

0.0

Posted On

13 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Case Processing, Pharmacovigilance, MedDRA, WHO-DD, Adverse Event Reporting, Post Marketing Surveillance, Clinical Trial Safety, Regulatory Compliance, Case Triage, Narrative Writing, QC Checks, Aggregate Reporting, SDEA, KPI/SLA Management, Literature ICSR Processing, Analytical Skills

Industry

Biotechnology Research

Description

Pharmacovigilance Associate (Hands-on experience in Clinical Trial & Post Marketing case processing) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Pharmacovigilance Associate at ICON, you will monitor and ensure the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. What You Will Be Doing: Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements Partner with cross-functional teams to address safety-related questions and support ongoing investigations Maintain current knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards Manage safety inbox and acknowledge case receipt. Perform case triage and book-in to safety database. Enter case details accurately and write narratives. Code events, drugs, and medical history using MedDRA/WHO-DD. Apply correct product labeling and perform QC checks. Finalize case processing and generate queries for follow-up Knowledge of seriousness, expectedness, causality, and global reporting Familiarity with reconciliation processes and aggregate reporting (PSUR/DSUR) Ability to mentor new joiners and review SOPs Working knowledge of SDEA and KPI/SLA basics Process literature ICSRs and maintain compliance with monitoring requirements Must Have Criteria: Minimum 2 years of experience in safety background, with direct involvement in case processing Solid experience in Post Marketing Surveillance/Clinical Trial case processing Bachelors degree in life sciences Strong analytical skills with attention to detail in data collection and reporting Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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 Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

The associate will collect, analyze, and process adverse event reports to ensure regulatory compliance and product safety. Responsibilities include case triage, narrative writing, coding using MedDRA/WHO-DD, and collaborating with cross-functional teams.