Drug Safety Physician

ICON; Chennai District; On-site; INR 1,800,000 - 2,400,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks

Life assurance

Flexible benefits

Job summary

ICON is a global healthcare intelligence and clinical research organisation committed to advancing patient lives. We are seeking a Drug Safety Physician to provide medical and safety support across ICON Project Teams, ensuring compliance with GCP, pharmacovigilance practices, and regulatory standards.

Qualified physicians with 2-3 years hospital experience and exposure to clinical research or pharmacovigilance are encouraged to apply.

Qualifications

• Qualified and licensed physician with 2-3 years of hospital experience.
• Experience in clinical research or pharmacovigilance preferred.

Responsibilities

• Provide medical and safety support to ICON Project Teams to ensure ethical principles, medical standards, GCP and pharmacovigilance compliance.
• Review coding (e.g., MedDRA) and assess Adverse Events and Adverse Drug Reactions for seriousness, relatedness, listedness, and expectedness.
• Review aggregated safety reports (e.g., patient profiles, line listings, safety reports) for product safety profile.
• Provide safety issue assessments in clinical trials or post-marketing settings and escalate to line manager as needed.
• Support regulatory requirements for expedited and periodic reporting of AEs/ADRs from trials, post-authorisation studies, and literature.
• Review and input to Project Specific Procedures and participate in meetings.
• Communicate with clients per Project Specific Procedures.
• Assist in preparation and conduct of code-break activities and input to core data sheets and product information.
• Provide PV consultancy to client on regulatory reporting requirements for AEs/ADRs.
• Guide Medical and Safety Services staff on regulatory AE reporting.
• Other responsibilities as assigned.

Skills

Medical knowledge

Clinical experience

Job description

Drug Safety Physician

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.

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Job Description

• We are looking for a Drug Safety Physician to provide medical and safety support to the activities of ICON Project Teams in order to ensure that projects are conducted according to the highest ethical principals and medical standards, in accordance with GCP and good pharmacovigilance practices and in compliance with applicable legal and regulatory standards.
• Review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious)
• Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile
• Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and elevate those to the line manager within ICON and discuss the agreed approach on resolution with the client
• Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature
• Review and provide input to the Project Specific Procedures and participate in project related meetings
• Communicate with the client to an extent as described in the Project Specific Procedures
• Provide assistance in the preparation and conduct of code-break activities
• Review, assess and provide input to Product Information, Company Core Data Sheet and any other product related information as required by the client in the course of assigned project
• Provide input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information
• Provide pharmacovigilance consultancy to the client in terms of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature
• Provide guidance to Medical and Safety Services staff with regards to the regulatory reporting of adverse event
• Other responsibilities as assigned

Role Requirements

• Qualified and licensed physician with 2-3 years of patient diagnosis and treatment experience in a hospital-based setup.
• Prior experience in clinical research or pharmacovigilance (Add-on)

Benefits of Working in ICON

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

What ICON can offer you

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.