Safety & PV Specialist – Literature Review & CAPA Management at Syneos Health

Syneos Health, a leading global biopharmaceutical solutions company, is hiring a Sr Safety & PV Specialist in Gurugram and Hyderabad. This role focuses on literature review, CAPA management, and pharmacovigilance (PV) quality support, ideal for professionals with experience in clinical safety, regulatory compliance, and post-marketing safety operations.

If you have a strong background in quality trend analysis, ICSR management, and safety database operations, this is your chance to advance your career in a globally recognized organization where your work directly impacts patient safety and clinical trial integrity.

Key Responsibilities

• Conduct systematic and ad-hoc literature searches using global biomedical databases (PubMed, Embase, Medline) for ICSR identification.
• Extract, summarize, and report key safety information from literature sources.
• Develop and validate search strategies for pharmacovigilance purposes, including local literature reviews.
• Support quality activities: Quality trend analysis, deviation management, Root Cause Analysis (RCA), and CAPA management.
• Participate in ICSR processing, including triaging, coding, data entry, and narrative summaries.
• Ensure regulatory compliance with global and local PV requirements (ICH GCP, GVP).
• Assist in preparation of Safety Management Plans and internal project review meetings.
• Provide training to investigators on ICSR reporting and support audits/inspections.
• Maintain accurate documentation in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).

Qualifications

• Educational Background: B.Pharm / M.Pharm / PharmD / BDS / BMS
• Experience: Minimum 2 years in literature review, quality review, and CAPA management.
• Strong knowledge of clinical trial processes (Phases II-IV), post-marketing safety, ICH GCP, and GVP regulations.
• Proficiency in Microsoft Office Suite and PV systems.
• Excellent communication, presentation, and organizational skills.
• Ability to work independently and in a team; detail-oriented with high accuracy.

Benefits

• Opportunity to work in a global biopharmaceutical leader impacting patient safety worldwide.
• Career development through training, mentorship, and skill enhancement.
• Supportive work culture promoting Total Self – diversity, inclusion, and well-being.
• Exposure to international regulatory standards and advanced PV systems.

Application Process

Application Link