Safety & Pharmacovigilance Specialist I – Quality Control (QC)
Location: Pune, India
Job Type: Full-Time
Experience Required: Minimum 3 Years
Last Updated: January 8, 2026
Job ID: 25104167
About the Company
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization delivering clinical development, medical affairs, and commercial expertise. Operating across more than 110 countries with a workforce of over 29,000 professionals, Syneos Health partners with leading pharmaceutical and biotechnology companies to accelerate therapies and improve patient outcomes worldwide.
With a strong focus on innovation, regulatory excellence, and patient-centric development, Syneos Health continues to support the majority of FDA- and EMA-approved products globally.
Job Overview
The Safety & Pharmacovigilance Specialist I (QC Experience) will support global pharmacovigilance operations with a focus on ICSR case processing, quality control, regulatory compliance, and safety data integrity. This role is ideal for professionals with hands-on experience in clinical trial, post-marketing, and spontaneous safety case processing who are looking to grow within a global drug safety environment.
Key Responsibilities
Pharmacovigilance & Case Processing
Enter, track, and manage Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and tracking systems.
Assist in end-to-end ICSR processing in compliance with SOPs, project-specific safety plans, and regulatory requirements.
Triage safety cases and assess data for completeness, accuracy, seriousness, and regulatory reportability.
Perform safety data entry, including adverse event coding, medical history, concomitant medications, and laboratory tests.
Compile high-quality narrative summaries and manage follow-ups until queries are satisfactorily resolved.
Support the preparation of expedited safety reports in accordance with global regulatory timelines.
Quality Control & Data Management
Perform quality review (QC) of ICSRs to ensure accuracy, consistency, and regulatory compliance.
Identify, assess, and manage duplicate safety cases.
Maintain safety tracking logs and documentation for assigned activities.
Conduct literature screening and review for safety reporting, including MedDRA coding and drug dictionary maintenance.
Support manual recoding of un-coded product and substance terms arising from ICSRs.
Regulatory & Compliance Activities
Validate and submit xEVMPD product records, including correct MedDRA coding of indication terms.
Support activities related to SPOR / IDMP compliance.
Ensure timely filing of safety documentation in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain strict compliance with ICH-GCP, GVP, global safety regulations, SOPs, and Work Instructions.
Participate in internal and external audits and inspections as required.
Apply Syneos Health regulatory intelligence to ongoing safety reporting activities.
Collaboration & Professional Conduct
Build and maintain effective working relationships with internal and external project stakeholders.
Support cross-functional pharmacovigilance and clinical development teams as required.
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent qualification
Acceptable disciplines include Life Sciences graduates, Registered Nurses, and Pharmacists
Experience
Minimum 3 years of experience in pharmacovigilance case processing, including Quality Control (QC) responsibilities
Proven experience handling Clinical Trial, Post-Marketing Surveillance (PMS), and Spontaneous safety cases
Technical & Regulatory Skills
Hands-on experience with safety databases and strong knowledge of medical terminology
Good understanding of clinical trial processes (Phases II–IV) and/or post-marketing safety requirements
Working knowledge of ICH-GCP, GVP, and global pharmacovigilance regulations
Professional Skills
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and document management systems
Strong attention to detail with high accuracy and deadline adherence
Ability to manage multiple tasks and priorities effectively
Excellent written and verbal communication skills
Ability to work independently as well as in a collaborative team environment
Why Join Syneos Health
Work on global safety programs supporting leading pharmaceutical products
Structured career development, technical training, and mentorship opportunities
Inclusive, diverse, and collaborative work culture
Opportunity to contribute directly to patient safety and regulatory compliance on a global scale
Over the past five years, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, across hundreds of global clinical and post-marketing programs.
Apply Now
Qualified pharmacovigilance professionals with QC experience are encouraged to apply through ThePharmaDaily.com and take the next step in their drug safety career.
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