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Drug Safety Associate

1-2 years
Not Disclosed
10 Nov. 13, 2025
Job Description
Job Type: Full Time Hybrid Remote 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

Position: Drug Safety Associate

Employer: ICON Strategic Solutions
Location: Mexico (Homeworking / Remote – CDMX)
Category: Pharmacovigilance / Drug Safety
Salary: Competitive
Start Date: 12 November 2025
Closing Date: 12 December 2025


About ICON

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are dedicated to driving innovation and excellence in clinical development and healthcare solutions. At ICON, we foster an inclusive and collaborative culture that empowers our teams to make a global impact by advancing life-changing therapies and improving patient outcomes.


Role Overview

As a Drug Safety Associate, you will play a key role in ensuring patient safety by supporting the collection, review, and assessment of adverse event data from clinical trials and post-marketing sources. This position is essential to maintaining compliance with global pharmacovigilance regulations and ensuring the safety profile of investigational and marketed products.


Key Responsibilities

  • Collect, review, and process adverse event (AE) reports from clinical trials and post-marketing sources in compliance with company SOPs and regulatory guidelines.

  • Perform initial case assessments and MedDRA coding of adverse events, ensuring accuracy and completeness.

  • Prepare and submit expedited safety reports to regulatory authorities, sponsors, and investigators as per reporting timelines.

  • Assist in developing and maintaining safety databases and case tracking systems.

  • Collaborate with cross-functional teams (clinical, regulatory, data management) to ensure timely communication of safety information.

  • Support the continuous improvement of pharmacovigilance workflows and documentation processes.


Your Profile

  • Education: Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or another healthcare-related discipline.

  • Experience:

    • 1–2 years of experience in pharmacovigilance or drug safety within the pharmaceutical, biotechnology, or CRO industry (preferred).

    • Knowledge of global pharmacovigilance regulations (ICH, FDA, EMA) and safety reporting processes.

  • Skills & Competencies:

    • Strong attention to detail with excellent analytical and problem-solving skills.

    • Ability to manage multiple priorities and work effectively in a fast-paced environment.

    • Excellent communication and organizational skills, with a collaborative mindset.

    • Proficiency in Microsoft Office applications and familiarity with safety databases (desirable).


What ICON Offers

At ICON, we believe that our success is built on the talent and dedication of our people. We offer a diverse, supportive, and rewarding environment that promotes career growth and work–life balance.

Benefits include (may vary by location):

  • Competitive annual leave entitlements.

  • Comprehensive health insurance options for you and your family.

  • Retirement planning and savings support for long-term financial security.

  • Global Employee Assistance Programme (LifeWorks): 24/7 confidential counseling and wellness support.

  • Life assurance coverage.

  • Flexible, country-specific benefits such as childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, and health assessments.

Visit our ICON Careers Site to learn more about our benefits.


Inclusion & Diversity

At ICON, inclusion and belonging are central to our values. We are committed to providing a workplace free of discrimination and harassment, ensuring equal opportunities for all employees regardless of race, color, religion, gender, sexual orientation, identity, nationality, or disability.

If you require a reasonable accommodation during the application process or to perform essential job functions due to a medical condition or disability, please contact our HR team for assistance.


How to Apply

If you are passionate about drug safety and global health, and even if you don’t meet every single requirement, we encourage you to apply. You might be exactly what we’re looking for — either for this role or another opportunity within ICON.

🔗 Current ICON employees: Please click here to apply internally.