Safety and Pharmacovigilance Coordinator (Office-Based)
Location: Hyderabad, India
Job ID: 25105305
Company: Syneos Health
Industry: Pharmacovigilance / Drug Safety / Clinical Research
Employment Type: Full-Time
Experience Required: Minimum 1 Year (PMS and Spontaneous Case Processing)
Updated: February 6, 2026
Job Overview
Syneos Health is hiring a Safety and Pharmacovigilance Coordinator to support global drug safety operations and regulatory compliance activities from its Hyderabad office. This role focuses on Individual Case Safety Report (ICSR) processing, safety data management, regulatory reporting, and pharmacovigilance compliance across clinical and post-marketing programs.
The position is ideal for pharmacy graduates with hands-on experience in pharmacovigilance systems, safety databases, and case processing workflows. The role contributes to patient safety, regulatory reporting accuracy, and global drug development initiatives within a dynamic clinical research environment.
Syneos Health is a global biopharmaceutical solutions organization dedicated to accelerating therapy development and improving patient outcomes worldwide.
Key Responsibilities
Enter safety data into pharmacovigilance quality and tracking systems for receipt and monitoring of Individual Case Safety Reports (ICSRs)
Process ICSRs in accordance with standard operating procedures and project-specific safety plans
Perform case triage and evaluate safety data for completeness, accuracy, and regulatory reportability
Enter and code adverse events, medical history, concomitant medications, and laboratory information in safety databases
Compile complete narrative summaries and follow up on missing or unclear information
Support timely and accurate expedited safety reporting in compliance with regulatory requirements
Maintain safety tracking systems for assigned pharmacovigilance activities
Conduct literature screening and safety data review activities
Perform MedDRA coding and maintain drug safety dictionaries
Validate and submit xEVMPD product records with appropriate indication coding
Perform manual recoding of product and substance terms arising from ICSRs
Identify and manage duplicate safety cases
Support SPOR and IDMP regulatory activities
Conduct quality review of safety cases and documentation
Ensure submission of relevant documents to Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with global regulations, including ICH GCP, GVP guidelines, and drug development processes
Collaborate with internal and external stakeholders to support safety reporting processes
Participate in audits, inspections, and quality assurance activities
Eligibility Criteria and Qualifications
B.Pharm or M.Pharm qualification (mandatory)
Minimum 1 year of experience in pharmacovigilance, including PMS and spontaneous case processing
Experience working with safety databases such as LSMV or Argus (preferred)
Knowledge of safety database systems and medical terminology
Understanding of clinical trial processes (Phases II–IV) and post-marketing safety requirements
Familiarity with ICH GCP, GVP, and global pharmacovigilance regulations
Proficiency in Microsoft Office Suite including Word, Excel, and PowerPoint
Strong analytical, organizational, and problem-solving abilities
Excellent written and verbal communication skills
Ability to work independently and collaboratively in a team environment
High attention to detail with strong time management skills
Preferred Skills
Experience in pharmacovigilance operations and safety reporting workflows
Knowledge of regulatory reporting requirements and compliance standards
Understanding of drug development lifecycle and risk management processes
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization with more than 29,000 employees across 110 countries. The company combines clinical development, medical affairs, and commercial expertise to accelerate therapy delivery and improve patient outcomes. Over the past five years, Syneos Health has supported 94 percent of novel FDA-approved drugs and 95 percent of EMA-authorized products, contributing to over 200 studies across 73,000 sites and more than 675,000 clinical trial participants globally.
Syneos Health promotes innovation, professional development, diversity, and a collaborative work environment dedicated to advancing global healthcare.
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