Safety & Pharmacovigilance Specialist
Updated: December 16, 2025
Location: China (Remote)
Job ID: 25104364
Employment Type: Full-Time
Industry: Pharmacovigilance / Drug Safety / Clinical Research
Note: This position is currently inactive; however, the role description is provided for talent pooling and future opportunities.
About Syneos Health
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining expertise across clinical development, medical affairs, and commercialization, Syneos Health delivers innovative solutions that address the evolving needs of global healthcare markets.
With more than 29,000 employees operating across 110 countries, Syneos Health follows a patient-centric Clinical Development model that prioritizes efficiency, scientific excellence, and regulatory compliance throughout the drug development lifecycle.
Position Overview
Syneos Health is seeking a Safety & Pharmacovigilance Specialist to support end-to-end pharmacovigilance activities across clinical and post-marketing programs. The role involves individual case safety report (ICSR) processing, safety database management, regulatory compliance, and collaboration with cross-functional teams to ensure high-quality safety data and timely reporting.
This position is well suited for professionals with hands-on experience in drug safety operations, regulatory reporting, and global pharmacovigilance requirements.
Key Responsibilities
Enter, track, and maintain Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and tracking systems in compliance with SOPs and project-specific safety plans.
Perform ICSR triage and assess cases for completeness, accuracy, seriousness, expectedness, and regulatory reportability.
Conduct safety data entry into validated safety databases, including coding of adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and WHO Drug Dictionary.
Prepare complete and scientifically accurate case narratives.
Identify missing or inconsistent information, generate follow-up queries, and ensure timely resolution.
Support the preparation and submission of expedited safety reports in compliance with global regulatory requirements.
Maintain safety tracking logs and documentation for assigned activities.
Perform literature screening and review for safety-relevant information.
Support drug coding activities, maintenance of drug dictionaries, and MedDRA coding updates.
Validate and submit xEVMPD product records, including accurate MedDRA coding of indication terms.
Perform manual recoding of un-recoded product and substance terms arising from ICSRs.
Identify, assess, and manage duplicate safety cases.
Support activities related to SPOR and IDMP compliance.
Perform quality review of ICSRs to ensure data integrity and regulatory compliance.
Ensure all relevant safety documents are filed in the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF) as per SOPs and sponsor requirements.
Maintain compliance with SOPs, Work Instructions, ICH-GCP, ICH guidelines, GVP modules, and global drug, biologic, and device regulations.
Collaborate effectively with internal and external project team members.
Participate in internal and external audits and inspections as required.
Apply regulatory intelligence updates provided by Syneos Health to all safety reporting activities.
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline.
Minimum 1–3 years of experience in Pharmacovigilance, Drug Safety, or Clinical Safety Operations.
Hands-on experience with safety database systems and strong knowledge of medical terminology.
Working knowledge of clinical trial processes (Phase II–IV) and/or post-marketing pharmacovigilance activities.
Good understanding of ICH-GCP, ICH guidelines, GVP modules, and global safety regulations.
Experience with MedDRA coding, drug coding, and literature case processing is preferred.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint), email systems, and collaborative work platforms.
Ability to work independently as well as collaboratively in a team-oriented environment.
Strong written and verbal communication skills.
Excellent organizational skills with the ability to manage multiple tasks and meet strict deadlines.
High attention to detail and commitment to data quality and compliance.
Career Impact and Growth
Roles within the Pharmacovigilance & Safety function contribute directly to patient safety and regulatory compliance across clinical development and post-marketing programs. Professionals in this role support medical safety evaluations, signal detection, risk management, and safety trend analysis while collaborating closely with clinical development teams.
This position represents an entry to early developing individual contributor role, offering opportunities to build strong expertise in global pharmacovigilance processes and regulatory frameworks.
About Syneos Health’s Global Impact
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
More than 200 clinical studies across 73,000 sites
Over 675,000 clinical trial patients worldwide
Equal Opportunity Statement
Syneos Health is committed to building a diverse, inclusive, and equitable workplace. Equivalent education, experience, and transferable skills may be considered. Reasonable accommodations are provided in accordance with applicable laws.
Stay Connected
Candidates who are not ready to apply are encouraged to join the Syneos Health Talent Network to receive updates on future Pharmacovigilance and Drug Safety opportunities.
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