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

Syneos Health

0-2 years

Not Disclosed

Pune

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)

Updated: October 31, 2025
Location: Pune, India (Hybrid)
Job ID: 25102440
Category: Safety / Pharmacovigilance
Company: Syneos Health®

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization that combines clinical development, medical affairs, and commercial insights to accelerate customer success and bring therapies to patients faster.

Our Core Focus:

Simplifying and streamlining operations to make Syneos Health easier to work with and for.
Centering our work around the customer and patient.
Operating with agility, innovation, and passion to transform lives through science.

Global Reach & Impact

Over the last 5 years, Syneos Health has:

Partnered in 94% of all FDA-approved novel drugs.
Contributed to 95% of EMA-authorized products.
Supported 200+ studies, 73,000 sites, and 675,000+ trial patients across 110 countries.

Tagline: Work Here Matters Everywhere.

Why Join Syneos Health

At Syneos Health, we are committed to building a workplace where you can authentically be yourself.

Key Highlights:

Career Growth & Development:
- Structured learning and advancement opportunities.
- Supportive, engaged leadership and mentoring.
- Technical and therapeutic area training.
Recognition & Rewards:
- Peer recognition and total rewards program.
- Competitive compensation packages.
Total Self Culture:
- A global culture that values individuality, inclusion, and belonging.
- Diversity of thought, background, and perspective is celebrated.

Our Commitment:
We continuously work to build the company we all want to work for — and that our customers want to work with.

Role Overview

The Safety Specialist II plays a critical role in ensuring patient safety and compliance across clinical trial programs. This role involves hands-on safety data evaluation, signal assessment, and collaboration across global teams to maintain the highest pharmacovigilance standards.

Key Responsibilities

Perform and review safety data collection and case processing from clinical trials.
Conduct adverse event (AE) and serious adverse event (SAE) evaluations.
Ensure compliance with Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Support preparation of safety deliverables, including narratives, periodic safety reports, and risk management summaries.
Collaborate cross-functionally with clinical operations, data management, and regulatory affairs.
Contribute to signal detection, safety data analysis, and documentation of findings.
Participate in process improvement initiatives and ensure audit readiness.

Qualifications

Required:

Hands-on clinical trial experience (mandatory).
Degree in Life Sciences, Pharmacy, Nursing, or a related discipline.
Understanding of pharmacovigilance operations, safety data flow, and global PV systems.

Preferred:

Prior experience in case processing, aggregate reporting, or signal detection.
Familiarity with safety databases (e.g., Argus, ARISg, or similar).
Strong attention to detail, analytical thinking, and communication skills.

Additional Information

Job duties listed are not exhaustive and may evolve based on business needs.
Equivalent qualifications, experience, or education may be considered.
Syneos Health adheres to equal opportunity, disability accommodation, and employment law compliance globally.
This posting does not constitute an employment contract.

How to Apply

Apply directly via Syneos Health Careers.
Not ready to apply? Join our Talent Network to receive updates on future opportunities.

Equal Opportunity Commitment

Syneos Health is dedicated to building a diverse, inclusive, and authentic workplace. Even if your experience does not align perfectly with every qualification, we encourage you to apply — transferable skills are valued.

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

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