Safety & PV Specialist II – CT Case processing Team at Syneos Health, Gurgaon, Haryana, India

Syneos Health is hiring a Safety & PV Specialist II for its CT Case processing Team in Gurgaon, Haryana, India. This is a full-time, on-site role. Responses are managed off LinkedIn.

Job Details

Company: Syneos Health

Job Title: Safety & PV Specialist II – CT Case processing Team

Location: Gurgaon, Haryana, India

Work Mode: On-site

Employment Type: Full-time

Job Description

Syneos Health is seeking an experienced Pharmacovigilance professional with strong expertise in Clinical Trial (CT) case processing and Medical Literature Monitoring (MLM). The successful candidate will be responsible for end-to-end ICSR management, literature review, coding activities, quality review, and regulatory compliance while supporting global safety operations and delivery excellence.

Key Responsibilities

  • Perform end-to-end processing of Individual Case Safety Reports (ICSRs), including case intake, data entry, coding, narrative writing, follow-up, and case completion within established timelines.
  • Enter and maintain safety information in Pharmacovigilance databases and tracking systems, ensuring accuracy, completeness, and compliance with project requirements.
  • Process literature-derived ICSRs in accordance with applicable SOPs, safety management plans, and regulatory requirements.
  • Conduct comprehensive literature screening, Medical Literature Monitoring (MLM), and literature review activities to identify potential adverse events and reportable safety information.
  • Evaluate case data for medical and regulatory completeness, accuracy, consistency, and reportability.
  • Perform MedDRA coding, drug coding, dictionary maintenance, and related coding activities as required.
  • Conduct quality review of safety cases to ensure adherence to regulatory guidelines, client expectations, and internal quality standards.
  • Identify, reconcile, and manage duplicate safety cases across safety databases and tracking systems.
  • Support regulatory data management activities including xEVMPD, SPOR, and IDMP-related validation and submission processes.
  • Assist with manual recoding of products, substances, indications, and related safety data when required.
  • Maintain accurate and audit-ready safety documentation in accordance with company, client, and regulatory requirements.
  • Ensure compliance with SOPs, Work Instructions, GVP, ICH-GCP guidelines, global pharmacovigilance regulations, and project-specific procedures.
  • Participate in audits, inspections, quality reviews, and continuous process improvement initiatives.
  • Apply pharmacovigilance expertise and regulatory intelligence to support compliant safety reporting and lifecycle management activities.
  • Collaborate effectively with cross-functional teams and global stakeholders to ensure successful project delivery and operational excellence.

Eligibility Criteria

Required Qualifications

  • M.Pharm, PharmD, B.Pharm, BDS, or an equivalent healthcare/life sciences qualification.
  • 4-7 years of Pharmacovigilance experience with a strong focus on Clinical Trial (CT) case processing.
  • Demonstrated experience in ICSR processing, case management, safety data entry, narrative writing, and follow-up activities.
  • Working knowledge of safety databases, MedDRA coding, drug dictionaries, and medical terminology.
  • Strong understanding of Clinical Trials, Pharmacovigilance regulations, ICH-GCP, GVP, and post-marketing safety requirements.
  • Experience conducting quality review activities and ensuring regulatory compliance.
  • Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
  • Ability to work independently while collaborating effectively within global and cross-functional teams.
  • Excellent written and verbal communication skills.
  • Strong analytical, organizational, and prioritization skills with the ability to manage multiple deliverables simultaneously.
  • High attention to detail, accuracy, quality, and compliance.

Required Skills

Preferred Skills

  • Experience with literature case processing and Medical Literature Monitoring (MLM).
  • Exposure to xEVMPD, SPOR, and IDMP requirements.
  • Knowledge of duplicate management and reconciliation activities.
  • Experience supporting audits, inspections, and regulatory submissions.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

How to Apply

Responses are managed off LinkedIn.

About Syneos Health

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. Syneos Health partners with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Over the past 5 years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

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Responses are managed off LinkedIn.