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Risk & Compliance Lead

ICON Clinical Research Poland sp. z.o.o.

Full time Hybrid
Location
Chennai
Work mode
Hybrid
Posted 17 hr ago Last checked 1 hr ago

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Role at a glance

You will
  • Your focus will be on monitoring risk and compliance, supporting the effective management of quality events and helping operational teams…
  • Monitor agreed **quality and compliance metrics**, identifying risks, trends and outliers and escalating potential non-compliance or areas…
  • Provide focused review and analysis of metrics for specific clients or projects when required.
Must-have skills
Clinical ResearchPharmacovigilanceRisk ManagementRoot Cause AnalysisStakeholder Management
Work mode
Hybrid

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Job description

Location: Chennai, India

Risk & Compliance Lead (PV/Safety)

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 **Risk & Compliance Lead at ICON**, you will support the delivery of quality, risk and compliance activities within our Safety operations.

This is an excellent opportunity for someone with experience in a regulated pharmaceutical, clinical research, Pharmacovigilance, Drug Safety, Quality or Compliance environment who enjoys using data and operational insight to identify risk, resolve quality issues and drive continuous improvement.

You will work closely with operational teams, supporting them in identifying emerging risks, managing quality events and maintaining high standards of compliance.

## What You Will Do

Your focus will be on monitoring risk and compliance, supporting the effective management of quality events and helping operational teams identify and resolve issues.

Key responsibilities include:

  • Monitor agreed **quality and compliance metrics**, identifying risks, trends and outliers and escalating potential non-compliance or areas requiring further action.
  • Provide focused review and analysis of metrics for specific clients or projects when required.
  • Support operational teams with the management of **Quality Events**, including deviations, **Corrective and Preventive Actions (CAPAs)** and audit findings.
  • Support investigations and **Root Cause Analysis (RCA)**, helping to identify underlying causes and appropriate corrective and preventive actions.
  • Assist operational teams with **audit and inspection readiness**, including preparation for and support during client audits and regulatory inspections.
  • Support the effective management and resolution of **audit and inspection findings**, working collaboratively with relevant stakeholders.
  • Contribute to **system and process optimisation initiatives**, using quality data and operational insight to identify opportunities for improvement.
  • Work cross-functionally to promote strong risk awareness and a culture of **quality, compliance and continuous improvement**.

## Your Profile

You will bring experience from a regulated environment, ideally within pharmaceutical, clinical research, Pharmacovigilance, Drug Safety, Quality or Compliance, combined with an understanding of how quality and regulatory requirements translate into operational delivery.

You will ideally have:

  • **Bachelor’s degree in life sciences, pharmacy, healthcare, law, business, quality, risk management, or a related field. A professional certification in quality, risk management or compliance is an advantage.**
  • Relevant experience within **Pharmacovigilance, Drug Safety, Quality, Compliance or another regulated pharmaceutical or clinical research environment**.
  • A good understanding of regulated operational processes and associated quality and compliance requirements.
  • Experience working with **quality metrics, deviations, CAPAs, audit findings and Root Cause Analysis**.
  • Exposure to **audits, inspections, compliance reviews or inspection-readiness activities**.
  • Strong analytical and problem-solving skills, with the ability to identify trends, outliers and areas of potential risk.
  • The ability to work collaboratively with operational teams to investigate issues and develop practical, sustainable solutions.
  • Strong communication and stakeholder management skills, with the confidence to raise and escalate risks appropriately.
  • The ability to manage competing priorities and follow actions through to resolution.
  • A proactive approach to **continuous improvement, quality and compliance**.

#LI-SB2

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](https://careers.iconplc.com/benefits) 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**](https://careers.iconplc.com/reasonable-accommodations).

Are you a current ICON Employee? Please click [here](https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) 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.

Job data: Headcount Labs (headcountlabs.com), ODbL 1.0. The job description belongs to the employer. Location data © OpenStreetMap contributors and Overture Maps.

Key skills

Required

Clinical ResearchPharmacovigilanceRisk ManagementRoot Cause AnalysisStakeholder Management

Soft skills

CommunicationProblem Solving

Tags

Job market insights

46active Clinical Research jobs in India
22active Pharmacovigilance jobs in India
48active Risk Management jobs in Chennai

Jobs asking for Clinical Research in India also ask for

  • MS Office35%
  • Clinical Data Management24%
  • Reconciliation22%
  • Pharmacovigilance17%
  • Clinical Trials15%

From live job posts on CoreHRx, updated 11 Nov 2026. Skill figures count posts that list their skills; salary figures only posts that show a salary.

Questions about this job

Where is this job based?

In Chennai (hybrid).

What kind of job is this?

It is a full time job.

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