Safety & Pharmacovigilance Specialist I
Updated: December 16, 2025
Location: China (Remote)
Job ID: 25104373
Employment Type: Full-Time
Job Function: Pharmacovigilance / Drug Safety
Career Level: Entry to Early Career
About Syneos Health
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers high-impact solutions that address complex global healthcare challenges.
With a workforce of over 29,000 professionals across 110 countries, Syneos Health operates a patient-centric Clinical Development model focused on innovation, regulatory excellence, and operational efficiency throughout the product lifecycle.
Role Overview
Syneos Health is seeking a Safety & Pharmacovigilance Specialist I to support global drug safety operations across clinical and post-marketing programs. This role is designed for early-career professionals with foundational pharmacovigilance knowledge who are looking to build hands-on experience in ICSR processing, safety database management, and global regulatory compliance.
The position plays a critical role in ensuring patient safety and regulatory adherence by supporting end-to-end pharmacovigilance activities in accordance with international standards.
Key Responsibilities
Enter and track Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and tracking systems in accordance with SOPs and study-specific safety plans.
Support end-to-end ICSR processing, including case triage and assessment for completeness, accuracy, seriousness, and regulatory reportability.
Perform safety data entry into validated safety databases, including coding of adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and drug dictionaries.
Prepare complete, accurate, and compliant case narratives.
Identify missing or inconsistent data, initiate follow-up queries, and ensure timely resolution.
Assist in the preparation and submission of expedited safety reports in compliance with global regulatory requirements.
Maintain safety tracking logs and documentation for assigned projects.
Conduct literature screening and review for safety-relevant information.
Support drug coding activities, MedDRA maintenance, and drug dictionary updates.
Assist in the validation and submission of xEVMPD product records, including appropriate MedDRA coding of indications.
Perform manual recoding of un-recoded product and substance terms arising from ICSRs.
Identify and manage duplicate safety cases.
Support SPOR and IDMP-related pharmacovigilance activities.
Perform quality review of ICSRs to ensure data integrity and regulatory compliance.
Ensure timely filing of safety documentation in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) in line with SOPs and sponsor requirements.
Maintain compliance with SOPs, Work Instructions, ICH-GCP, ICH guidelines, GVP modules, and global safety regulations.
Collaborate effectively with internal and external project stakeholders.
Participate in audits, inspections, and regulatory readiness activities as required.
Apply regulatory intelligence updates provided by Syneos Health to daily safety operations.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline.
0–2 years of experience in Pharmacovigilance, Drug Safety, Clinical Safety, or a related domain (fresh graduates with relevant training may be considered).
Basic hands-on experience or training in safety database systems and medical terminology.
Foundational understanding of clinical trial processes (Phase II–IV) and/or post-marketing pharmacovigilance requirements.
Knowledge of ICH-GCP, ICH guidelines, GVP modules, and global safety regulations.
Familiarity with MedDRA coding, drug dictionaries, and literature case processing is preferred.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and collaborative work tools.
Ability to work independently and within a team-oriented environment.
Strong written and verbal communication skills in English.
Excellent organizational skills with attention to detail and the ability to manage multiple tasks.
Career Development and Impact
This role falls within the Pharmacovigilance & Safety job family and offers an excellent foundation for building a long-term career in drug safety. Professionals in this role contribute to patient safety, regulatory compliance, safety trend analysis, and risk management while gaining exposure to global clinical development programs.
This is an entry-level to early developing individual contributor role, focused on smaller, less complex projects under guidance, with opportunities for growth into advanced pharmacovigilance and safety leadership roles.
Syneos Health Global Impact
Over the past five years, Syneos Health has supported:
94% of newly approved FDA drugs
95% of EMA-authorized products
More than 200 clinical studies across 73,000 sites
Over 675,000 clinical trial participants worldwide
Equal Opportunity Statement
Syneos Health is committed to fostering a diverse, inclusive, and equitable workplace. Candidates with transferable skills or equivalent experience are encouraged to apply. Reasonable accommodations are provided in accordance with applicable laws.
How to Apply
Interested candidates may apply directly or join the Syneos Health Talent Network to receive updates on future Pharmacovigilance and Drug Safety opportunities.
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