Safety & Pharmacovigilance Specialist I – Quality Control (QC)
Location: Hyderabad, India
Job Type: Full-Time
Experience Required: Minimum 3 Years
Last Updated: January 8, 2026
Job ID: 25104167
About Syneos Health
Syneos Health® is a leading global biopharmaceutical solutions organization that integrates clinical development, medical affairs, and commercial expertise to accelerate customer success. With operations across more than 110 countries and a workforce of over 29,000 professionals, Syneos Health partners with top pharmaceutical and biotechnology companies to deliver therapies that improve patient lives worldwide.
Our patient-centric Clinical Development model ensures efficiency, quality, and innovation across the drug development lifecycle.
Job Overview
The Safety & PV Specialist I (QC Experience) role is responsible for supporting global pharmacovigilance operations with a strong focus on ICSR case processing, quality control, regulatory compliance, and safety data accuracy. This position is ideal for professionals with hands-on experience in clinical trial and post-marketing safety who are seeking growth in a structured global pharmacovigilance environment.
Key Responsibilities
Pharmacovigilance & Case Processing
Enter, track, and manage Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and safety databases.
Support end-to-end ICSR processing in compliance with SOPs, project-specific safety plans, and regulatory timelines.
Triage safety cases and evaluate data for completeness, accuracy, seriousness, and reportability.
Perform safety data entry including adverse events, medical history, concomitant medications, and laboratory tests.
Prepare high-quality narrative summaries and manage follow-ups until resolution of queries.
Assist in the preparation and submission of expedited safety reports in accordance with global regulatory requirements.
Quality Control & Data Management
Perform quality checks (QC) on ICSRs to ensure accuracy, consistency, and regulatory compliance.
Identify 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 products and substances arising from ICSRs.
Regulatory & Compliance Activities
Validate and submit xEVMPD product records, including accurate 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 compliance with ICH-GCP, GVP, global drug 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 effective working relationships with cross-functional teams and external stakeholders.
Support pharmacovigilance and clinical development teams with safety expertise as required.
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent qualification
Acceptable backgrounds include Life Sciences graduates, Registered Nurses, and Pharmacists
Experience
Minimum 3 years of experience in pharmacovigilance case processing, including Quality Control (QC)
Hands-on experience with Clinical Trial, Post-Marketing Surveillance (PMS), and Spontaneous safety cases
Technical & Regulatory Skills
Working knowledge of safety databases and medical terminology
Good understanding of clinical trial phases (II–IV) and post-marketing safety requirements
Familiarity with ICH-GCP, GVP, and global pharmacovigilance regulations
Professional Skills
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and document management tools
Strong attention to detail with the ability to meet regulatory timelines
Excellent written and verbal communication skills
Strong organizational and multitasking abilities
Ability to work independently as well as collaboratively in a team environment
Why Join Syneos Health
Opportunity to work on global pharmacovigilance programs supporting leading therapies
Structured career growth, training, and development opportunities
Inclusive, diverse, and people-focused work culture
Direct contribution to patient safety and regulatory excellence
Over the past five years, Syneos Health has supported 94% of 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 advance their careers in global drug safety.
Not ready to apply? Join the Talent Network to stay updated on future pharmacovigilance and drug safety opportunities.
Job Category: Pharmacovigilance & Drug Safety
SEO Keywords: Safety PV Specialist Jobs Hyderabad, Pharmacovigilance QC Jobs India, ICSR Case Processing Jobs, Drug Safety Careers, Entry-Level PV Specialist, Clinical Safety Jobs, Post-Marketing Surveillance Roles
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