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

0-2 years

Not Disclosed

Hyderabad India

10 Nov. 5, 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)

Updated: October 31, 2025
Location: Hyderabad, India (Hybrid)
Job ID: 25102440
Department: Pharmacovigilance / Safety
Organization: Syneos Health®

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. The company unites clinical development, medical affairs, and commercial insights to drive better outcomes and address modern market challenges.

Key Highlights:

Operates in 110 countries with 29,000+ employees worldwide
Collaborated on 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the past five years
Supported 200+ studies across 73,000 sites and 675,000+ trial patients

Company Vision

At Syneos Health, patients and customers are at the center of everything we do. We continually streamline our processes to make the organization easier to work with and for.

Whether in a Functional Service Provider (FSP) model or a Full-Service environment, our teams of innovative, passionate professionals work collaboratively to accelerate life-changing therapies to market.

Tagline: Work Here Matters Everywhere.

Why Join Syneos Health

Career Development & Growth:
- Comprehensive learning and progression pathways
- Supportive line management and mentoring
- Technical and therapeutic area training
Total Self Culture:
- Encourages authenticity and diversity
- Fosters inclusion, belonging, and respect for all backgrounds
Recognition & Rewards:
- Peer recognition programs
- Competitive compensation and total rewards package

Our Belief:
When diverse perspectives come together, innovation thrives — creating an environment where everyone feels valued and empowered.

Job Summary

The Safety Specialist II plays a crucial role in supporting pharmacovigilance operations, ensuring accurate processing, review, and evaluation of safety data from clinical trials. This position requires prior hands-on experience in clinical trial safety and adherence to global safety standards.

Key Responsibilities

Perform safety data collection, case processing, and evaluation for clinical trial reports.
Review, analyze, and assess adverse events and serious adverse events (SAEs).
Ensure compliance with GCP, ICH, and regulatory requirements.
Support preparation of safety deliverables, such as case narratives, periodic reports, and signal detection summaries.
Collaborate with internal and cross-functional teams, including clinical operations, regulatory, and data management.
Maintain documentation as per Standard Operating Procedures (SOPs) and quality standards.
Participate in ongoing process improvement initiatives within the safety function.

Qualifications

Required:

Proven Clinical Trial experience (mandatory).
Relevant degree in Life Sciences, Pharmacy, Nursing, or related field.
Strong understanding of pharmacovigilance principles and clinical research processes.

Preferred:

Experience in case processing, signal detection, or aggregate safety reporting.
Knowledge of global safety regulations and PV databases (e.g., Argus, ARISg, or equivalent).
Excellent attention to detail, communication, and analytical skills.

Additional Information

Tasks and responsibilities listed are not exhaustive and may evolve as needed.
Equivalent experience, education, or skills may be considered.
Syneos Health complies with equal opportunity, disability accommodation, and employment legislation across all operating regions.
No employment contract is implied by this posting.

How to Apply

Apply directly through Syneos Health Careers.
Not ready to apply? Join our Talent Network to stay updated on future opportunities.

Equal Opportunity Statement

Syneos Health is committed to fostering a diverse, inclusive, and authentic workplace. Even if your past experience does not perfectly align with every qualification, you are encouraged to apply — transferable skills are valued.

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

Job Description

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