Senior Safety & Pharmacovigilance Specialist – Literature Review, Compliance Program (CP) & CAPA Management
Location: Hyderabad or Gurugram, India (Office-Based)
Category: Drug Safety / Pharmacovigilance
Employment Type: Full-Time
Experience Required: Minimum 2+ years in literature review and PV quality review
Syneos Health, a leading global biopharmaceutical solutions organization, is seeking a Senior Safety & Pharmacovigilance (PV) Specialist to support literature review, compliance program activities, deviation management, and CAPA oversight. This role is ideal for pharmacovigilance professionals with hands-on experience in global literature surveillance, ICSR management, and quality systems within clinical development and post-marketing environments.
Operating across 110+ countries, Syneos Health partners with sponsors to accelerate clinical development and deliver innovative therapies worldwide. This Hyderabad/Gurugram-based role offers the opportunity to contribute to global safety operations aligned with ICH, GCP, and GVP standards.
Key Responsibilities
Global Literature Review & Case Management
Conduct systematic and ad-hoc searches in biomedical databases such as Embase, PubMed, and Medline for safety signal detection and ICSR identification.
Develop, validate, and optimize search strategies aligned with global pharmacovigilance requirements.
Extract, analyze, and summarize safety-relevant information from published literature.
Perform local literature review activities in compliance with regional regulatory frameworks.
ICSR Processing & Safety Reporting
Triage and assess ICSRs for completeness, regulatory reportability, and data accuracy.
Enter and code adverse events, medical history, medications, and laboratory data in safety databases.
Prepare narrative summaries and follow up on queries to ensure data resolution.
Support expedited reporting and periodic safety submissions in compliance with global regulations.
Coordinate reconciliation between clinical and safety databases.
Quality & Compliance Management
Support quality trend analysis, deviation management, root cause analysis (RCA), and CAPA implementation.
Prepare and contribute to Safety Management Plans.
Participate in audits and regulatory inspections as required.
Ensure submission of essential documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP guidelines, and global drug safety regulations.
Stakeholder & Operational Support
Coordinate workflow to ensure timely project delivery.
Present safety data and quality metrics to internal teams and external clients.
Provide training to investigators on ICSR reporting requirements.
Education & Experience Requirements
Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), PharmD, BDS, or BMS.
Minimum 2+ years of experience in pharmacovigilance literature review and literature case management.
Demonstrated experience in quality review activities including deviation management, trend analysis, RCA, and CAPA management.
Strong understanding of clinical trial phases (II–IV) and post-marketing safety requirements.
Knowledge of ICH-GCP, GVP, global pharmacovigilance regulations, and safety reporting standards.
Experience with safety database systems and medical terminology.
Technical & Professional Competencies
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and shared document platforms.
Strong analytical skills with high attention to detail and accuracy.
Ability to manage multiple priorities and meet strict deadlines.
Effective communication and presentation skills with client-facing capabilities.
Ability to work independently and collaboratively within cross-functional global teams.
Willingness to travel up to 10% if required.
Why Join Syneos Health?
Syneos Health has supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years. With experience across thousands of clinical sites and hundreds of thousands of trial participants globally, the organization plays a critical role in advancing drug development and patient safety.
Professionals joining this team contribute directly to global pharmacovigilance excellence, regulatory compliance, and patient safety initiatives across clinical and post-marketing programs.
Job Location: Hyderabad or Gurugram, India
Employment Type: Full-Time
Functional Area: Pharmacovigilance / Drug Safety / Quality & Compliance
Experience Level: Mid-Level (2+ Years Required)
Syneos Health is committed to building a diverse and inclusive workplace and provides equal employment opportunities in accordance with applicable regulations.
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