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

0-2 years
Not Disclosed
10 Nov. 6, 2025
Job Description
Job Type: Full Time 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: Salem, TN, India
Job ID: 25102440-OTHLOC-5447-2DH


Company Overview

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We connect clinical, medical affairs, and commercial expertise to deliver impactful outcomes in the real world.

With 29,000 employees across 110 countries, Syneos Health is driven by innovation and collaboration to improve patient lives and make a global difference.

Website: www.syneoshealth.com


Why Join Syneos Health

  • Strong focus on career development and progression

  • Supportive, engaged line management and technical/therapeutic training

  • Total Rewards Program and peer recognition

  • Inclusive “Total Self” culture that encourages authenticity and belonging

  • Commitment to diversity, equality, and well-being across all teams


Key Highlights

  • Worked on 94% of all FDA-approved novel drugs and 95% of EMA-authorized products in the last 5 years

  • Supported 200+ studies across 73,000 sites and 675,000+ trial patients

  • Global impact through Functional Service Provider and Full-Service partnerships


Position Summary

The Safety Specialist II will be responsible for supporting pharmacovigilance and safety operations within clinical trials. The role requires prior clinical trial experience and the ability to collaborate across teams to ensure accurate safety reporting, assessment, and documentation in compliance with global regulations.


Key Responsibilities

  • Perform safety case processing and documentation for clinical trial data

  • Assess and evaluate safety information according to protocol requirements

  • Support signal detection and risk management activities

  • Collaborate cross-functionally to maintain compliance with regulatory standards

  • Contribute to continuous improvement of safety processes and systems


Qualifications

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field

  • Relevant clinical trial experience (mandatory)

  • Strong knowledge of pharmacovigilance regulations and ICH guidelines

  • Excellent written and verbal communication skills

  • Ability to work independently and in a hybrid team environment


Additional Information

  • This job description is not exhaustive; additional duties may be assigned.

  • Syneos Health complies with all local and international employment laws, including the EU Equality Directive and the Americans with Disabilities Act (ADA).

  • Reasonable accommodations will be provided when appropriate.


How to Apply

👉 Apply Here
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