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Safety Specialist Ii - Clinical Trial Exp (Must Have) - Hybrid

0-2 years
Not Disclosed
10 Nov. 5, 2025
Job Description
Job Type: Full Time Hybrid 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:

Safety Specialist II – Clinical Trial Experience (Must Have) – HYBRID

Updated: October 31, 2025
Location: IND – Gurugram – Hybrid
Job ID: 25102440


About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. By combining clinical, medical affairs, and commercial expertise, we transform insights into outcomes and bring innovative therapies to patients faster.

Our Clinical Development model places both the customer and the patient at the center of everything we do. We continuously work to simplify, innovate, and streamline processes — making Syneos Health easier to work with and for.

Whether you join us through a Functional Service Provider (FSP) partnership or in a Full-Service environment, you will collaborate with passionate professionals dedicated to helping clients achieve their goals.

At Syneos Health, we are agile, innovative, and united by one purpose — to change lives.


Why Work With Us?

  • Global Impact: 29,000 employees across 110 countries.

  • Industry Leadership: Partnered with

    • 94% of all Novel FDA Approved Drugs

    • 95% of EMA Authorized Products

    • Over 200 clinical studies across 73,000 sites involving 675,000+ trial patients.

  • Commitment to People:

    • Comprehensive career development and progression pathways.

    • Supportive, engaged line management and mentorship.

    • Technical and therapeutic training programs.

    • Peer recognition and total rewards program.

  • Inclusive Culture:

    • Total Self Culture” encourages authenticity and belonging.

    • A workplace built on diversity of thoughts, cultures, and backgrounds.

At Syneos Health, WORK HERE MATTERS EVERYWHERE.


Key Responsibilities

  • Perform pharmacovigilance and safety case processing activities related to clinical trials.

  • Review, evaluate, and document adverse event reports in compliance with global regulatory standards.

  • Maintain data integrity within safety databases and ensure timely case submissions.

  • Support safety reporting for ongoing and post-marketing studies.

  • Collaborate cross-functionally with internal and external stakeholders to ensure compliance and quality.

  • Participate in audits and contribute to continuous process improvement initiatives.

(Note: Detailed responsibilities may vary by project or assignment.)


Qualifications & Skills

  • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related discipline.

  • Clinical trial experience is mandatory.

  • Proficiency with safety databases (e.g., Argus, ARISg, or similar).

  • Understanding of ICH-GCP guidelines, global safety regulations, and MedDRA coding.

  • Excellent attention to detail, analytical thinking, and written communication skills.

  • Ability to work independently in a hybrid team environment.


Additional Information

  • The listed tasks and duties are not exhaustive; the company may assign additional responsibilities as needed.

  • Equivalent education, skills, or experience may be considered in place of listed qualifications.

  • Syneos Health complies with all applicable employment and equality laws, including the EU Equality Directive and ADA (Americans with Disabilities Act), providing reasonable accommodations where necessary.

  • This posting does not constitute an employment contract.


How to Apply

  • Apply Now: Visit Syneos Health Careers

  • Not ready to apply? Join our Talent Network to receive updates on future career opportunities.


Equal Opportunity Statement

At Syneos Health, we are committed to building a diverse, inclusive, and authentic workplace.
If your experience does not align perfectly with the role, we still encourage you to apply — transferable skills and potential are highly valued.